Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
621
Countries
16
Sites
60
Multiple Myeloma
To compare the efficacy of bortezomib, lenalidomide, and dexamethasone (VRd) induction followed by a single administration of cilta-cel versus VRd induction followed by lenalidomide and dexamethasone (Rd) maintenance in terms of progression-free survival (PFS).
Key facts
- Sponsor
- Janssen - Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Aug 2021 → ongoing
- Decision date (initial)
- 2024-04-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-505850-16-00
- EudraCT number
- 2021-001242-35
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacokinetic, Efficacy, Others, Pharmacodynamic
To compare the efficacy of bortezomib, lenalidomide, and
dexamethasone (VRd) induction followed by a single administration of
cilta-cel versus VRd induction followed by lenalidomide and
dexamethasone (Rd) maintenance in terms of progression-free survival (PFS).
Conditions and MedDRA coding
Multiple Myeloma
Regulatory references
- Scientific advice from competent authorities
- Medicines And Healthcare Products Regulatory Agency, National Agency For The Safety Of Medicine And Health Products, European Medicines Agency, Paul-Ehrlich-Institut, Federal Joint Committee, Spanish Agency For Medicines And Health Products
- Plan to share IPD
- Yes
- IPD plan description
- The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- 1. ≥18 years of age
- 2. Documented diagnosis of MM according to IMWG diagnostic criteria
- 3. Measurable disease at Screening
- 4. Not considered for high-dose chemotherapy with autologous stem cell transplant (ASCT)
- 5. Eastern Cooperative Oncology Group Performance Status grade of 0 or 1 Contraceptive/Barrier Requirements
- 6. A woman of childbearing potential (WOCBP) must have 2 negative highly sensitive serum or urine pregnancy test (beta-human chorionic gonadotropin) tests prior to starting VRd and must agree to further testing during the study.
- 7. When a woman is of childbearing potential, the participant must commit either to abstaining continuously from heterosexual intercourse or agree to practice 2 methods of reliable birth control simultaneously, ie, one highly effective method of contraception (failure rate of <1% per year when used consistently and correctly; see examples below) and one other effective method (ie, male latex or synthetic condom, diaphragm, or cervical cap).
- 8. A man must commit either to abstaining continuously from heterosexual intercourse or a man • Who is sexually active with a WOCBP or a pregnant woman must agree to use a barrier method of contraception (eg, latex or synthetic condom with spermicidal foam/gel/film/cream/suppository), without interruption, from the time of signing the informed consent form (ICF) until at least 4 weeks after the last dose of lenalidomide, 3 months after the last dose of bortezomib, 1 year after receiving the conditioning regimen (cyclophosphamide and fludarabine) or 1 year after receiving cilta-cel infusion (whichever is later), even if they have undergone a successful vasectomy. • Should agree to practice contraception according to and for the time frame specified in the global REVLIMID® ( or generic lenalidomide) pregnancy prevention program or equivalent local REVLIMID® (or generic lenalidomide) pregnancy prevention program, whichever is more stringent.
- 9. Women and men must agree not to donate eggs (ova, oocytes) or sperm, respectively, during the study and until at least 4 weeks after the last dose of lenalidomide, 3 months after the last dose of bortezomib, 1 year after receiving the conditioning regimen (cyclophosphamide and fludarabine), or 1 year after receiving cilta-cel infusion (whichever is later).
Exclusion criteria 17
- 1. Frailty index of ≥ 2 according to Myeloma Geriatric Assessment score
- 2. Active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study.
- 3.Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.
- 4. The following cardiac conditions: • New York Heart Association Stage III or IV congestive heart failure • Myocardial infarction or coronary artery bypass graft ≤6 months prior to enrollment • History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration • History of severe non-ischemic cardiomyopathy • Screening 12-lead ECG showing a baseline corrected Prolonged corrected QT interval (QTc) >470 msec (for women) and >450 msec (for men), as assessed by 12-lead ECG, except in participants with a pacemaker. • Impaired cardiac function (left ventricular ejection fraction <45%) as assessed by echocardiogram or multiple-gated acquisition (MUGA) scan.
- 5. Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM.
- 6.Stroke or seizure within 6 months of signing ICF.
- 7.Plasma cell leukemia at the time of screening (>2.0 x 10^9/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.
- 8. Seropositive for human immunodeficiency virus (HIV).
- 9. Vaccinated with live, attenuated vaccine within 4 weeks prior to first dose of VRd.
- 10. Hepatitis B infection. In the event the infection status is unclear, quantitative levels are necessary to determine the infection status.
- 11. Hepatitis C infection (defined as anti-hepatitis C virus [HCV] antibody positive or detectable HCV-RNA) or known to have a history of hepatitis C.
- 12. Participant must not require continuous supplemental oxygen.
- 13. Contraindications, known life-threatening allergies, hypersensitivity, or intolerance to any of the study treatments, including cyclophosphamide or fludarabine (if known) or any of their excipients, including boron, mannitol, dimethyl sulfoxide.
- 14. Serious underlying medical condition, such as: • Evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection • Active autoimmune disease • Overt clinical evidence of dementia or altered mental status • Any history of Parkinson's disease or other neurodegenerative disorder Prior/Concomitant Medications.
- 15. Prior treatment with CAR-T therapy directed at any target.
- 16. Any therapy that is targeted to BCMA.
- 17. Any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids and/or maximum 1 cycle of VRd therapy prior to enrollment. •Radiation therapy for treatment of plasmacytoma within 14 days before enrollment (palliative radiation for pain control secondary to lytic lesion is allowed within 14 days of enrollment). However, if the radiation portal covered ≤5% of the bone marrow reserve, the subject is eligible irrespective of the end date of radiation therapy.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Progression-free survival (PFS) with progression defined by IMWG criteria, or death, whichever occurred first.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
CARVYKTI 3.2 × 10^6 – 1.0 × 10^8 cells dispersion for infusion
PRD9718535 · Product
- Active substance
- Ciltacabtagene Autoleucel
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 Kg kilogram(s)
- Max total dose
- 0 Kg kilogram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XL05 — -
- Marketing authorisation
- EU/1/22/1648/001
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/20/2252
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The clinical trial will be conducted with "clinical" material. Compared to the authorized product, the same CAR-T drug product manufacturing process is used. For the lentiviral vector process, the only difference is that the lentiviral vector manufacturing process may differ from the authorized product, e.g. the adherent process instead of the suspension process.
Comparator 28
VELCADE 3.5 mg powder for solution for injection
PRD703624 · Product
- Active substance
- Bortezomib
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 168 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XG01 — -
- Marketing authorisation
- EU/1/04/274/001
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Clinical label attched to each vial and re-packaged
Lenalidomide Accord 5 mg hard capsules
PRD6773394 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/004
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Lenalidomide Accord 15 mg hard capsules
PRD6773398 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/008
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Lenalidomide Accord 15 mg hard capsules
PRD6773399 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/009
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Lenalidomide Accord 10 mg hard capsules
PRD6773396 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/006
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Lenalidomide Accord 2.5 mg hard capsules
PRD6773391 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/001
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Lenalidomide Accord 25 mg hard capsules
PRD6773401 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/011
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Lenalidomide Accord 25 mg hard capsules
PRD9244619 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/014
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Lenalidomide Accord 5 mg hard capsules
PRD6773393 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/003
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Lenalidomide Accord 10 mg hard capsules
PRD6773397 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/007
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Lenalidomide Accord 20 mg hard capsules
PRD6773400 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/010
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Lenalidomide Accord 20 mg hard capsules
PRD9244618 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/013
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Lenalidomide Accord 2.5 mg hard capsules
PRD6773392 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/18/1316/002
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
PRD10324898 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 9587.01.00
- MA holder
- MERCK HEALTHCARE GERMANY GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Mylan 10 mg hard capsules
PRD8601764 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/20/1490/010
- MA holder
- MYLAN IRELAND LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Lenalidomide Mylan 20 mg hard capsules
PRD9024381 · Product
- Active substance
- Lenalidomide
- Substance synonyms
- 3-(7-AMINO-3-OXO-1H-ISOINDOL-2-YL)PIPERIDINE-2,6-DIONE, 3-(4'aminoisoindoline-1'-one)-1-piperidine-2,6-dione, CDC-501, SYP-1512, CC-5013
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/20/1490/025
- MA holder
- MYLAN IRELAND LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Lenalidomide Mylan 25 mg hard capsules
PRD8601772 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/20/1490/018
- MA holder
- MYLAN IRELAND LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Lenalidomide Mylan 2.5 mg hard capsules
PRD8601757 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/20/1490/003
- MA holder
- MYLAN IRELAND LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Lenalidomide Mylan 10 mg hard capsules
PRD9024379 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/20/1490/023
- MA holder
- MYLAN IRELAND LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Lenalidomide Mylan 25 mg hard capsules
PRD9024382 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/20/1490/026
- MA holder
- MYLAN IRELAND LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Lenalidomide Mylan 2.5 mg hard capsules
PRD9024375 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/20/1490/019
- MA holder
- MYLAN IRELAND LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Lenalidomide Mylan 5 mg hard capsules
PRD9024376 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/20/1490/020
- MA holder
- MYLAN IRELAND LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Lenalidomide Mylan 20 mg hard capsules
PRD8601769 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/20/1490/015
- MA holder
- MYLAN IRELAND LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Lenalidomide Mylan 5 mg hard capsules
PRD8601759 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/20/1490/005
- MA holder
- MYLAN IRELAND LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Lenalidomide Mylan 15 mg hard capsules
PRD8601766 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/20/1490/012
- MA holder
- MYLAN IRELAND LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Lenalidomide Mylan 15 mg hard capsules
PRD9024380 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/20/1490/024
- MA holder
- MYLAN IRELAND LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Dexamethasone Tablets BP 2.0mg
PRD3570594 · Product
- Active substance
- Dexamethasone Ph. Eur.
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- PL 39699/0056
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
PRD988426 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 40153.00.00
- MA holder
- MIBE GMBH ARZNEIMITTEL
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- re-labeling and packaging
Auxiliary 2
SCP130444 · ATC
- Active substance
- Cyclophosphamide
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg/m2 milligram(s)/sq. meter
- Max total dose
- 0 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP146752 · ATC
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg/m2 milligram(s)/sq. meter
- Max total dose
- 0 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen - Cilag International
- Sponsor organisation
- Janssen - Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| Hematogenix Laboratory Services LLC ORG-100040020
|
Tinley Park, United States | Laboratory analysis |
| Hematogenix Laboratory Services Limited ORG-100047188
|
Cheadle, United Kingdom | Laboratory analysis |
| Yprime LLC ORG-100042888
|
Malvern, United States | E-data capture |
| Cerba Research ORG-100042694
|
Gent, Belgium | Laboratory analysis |
| SGS Belgium ORG-100007917
|
Mechelen, Belgium | Data management |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Data management |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | Other |
| Ancillare LP ORG-100044089
|
Horsham, United States | Other |
| Signant Health LLC ORG-100040732
|
Blue Bell, United States | Interactive response technologies (IRT) |
| CMT Cellex Manufacturing Transports and Logistics GmbH ORG-100026399
|
Cologne, Germany | Laboratory analysis |
| Pharmaceutical Product Development LLC ORG-100016999
|
Wilmington, United States | Data management |
| Smithers PDS LLC ORG-100040403
|
Gaithersburg, United States | Laboratory analysis |
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Laboratory analysis |
Locations
16 EU/EEA countries · 60 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 14 | 3 |
| Belgium | Ongoing, recruitment ended | 11 | 2 |
| Czechia | Ongoing, recruitment ended | 33 | 4 |
| Denmark | Ongoing, recruitment ended | 15 | 3 |
| Finland | Ongoing, recruitment ended | 9 | 3 |
| France | Ongoing, recruitment ended | 11 | 4 |
| Germany | Ongoing, recruitment ended | 54 | 11 |
| Greece | Ongoing, recruitment ended | 13 | 3 |
| Hungary | Ongoing, recruitment ended | 2 | 1 |
| Ireland | Ongoing, recruitment ended | 4 | 1 |
| Netherlands | Ongoing, recruitment ended | 21 | 3 |
| Norway | Ongoing, recruitment ended | 12 | 1 |
| Poland | Ongoing, recruitment ended | 78 | 6 |
| Portugal | Ongoing, recruitment ended | 10 | 2 |
| Spain | Ongoing, recruitment ended | 78 | 11 |
| Sweden | Ongoing, recruitment ended | 6 | 2 |
| Rest of world
Korea, Republic of, Australia, Israel, United States, Canada, United Kingdom, Switzerland, Japan, Brazil, Argentina
|
— | 250 | — |
Investigational sites
SCRI CCCIT Ges.m.b.H.
Universitaetsklinik fuer Innere Medizin III, Muellner Hauptstrasse 48, 5020, Salzburg
Medical University Of Vienna
Klin. Abteilung für Hämatologie und Hämostaseologie, Waehringer Guertel 18-20, Alsergrund, Vienna
Ordensklinikum Linz GmbH
Hämatologie & Onkologie, Fadingerstrasse 1, 4020, Linz
Az St-Jan Brugge-Oostende A.V.
Hematologie, Ruddershove 10, 8000, Brugge
Antwerp University Hospital
Hematologie, Drie Eikenstraat 655, 2650, Edegem
Fakultni Nemocnice Hradec Kralove
IV. interni hematologicka klinika, Sokolska 581, 500 03, Novy Hradec Kralove
Vseobecna Fakultni Nemocnice V Praze
I. Interni klinika - klinika hematologie, U Nemocnice 499/2, Nove Mesto, Prague
Fakultni Nemocnice Ostrava
Klinika hematoonkologie, 17. Listopadu 1790/5, Poruba, Ostrava
Fakultni Nemocnice Brno
Interni hematologicka a onkologicka klinika, Jihlavska 340/20, Bohunice, Brno
Odense University Hospital
Department of Hematology, J B Winsloews Vej 4, 5000, Odense C
Rigshospitalet
Dept of Hematology 2081, Inge Lehmanns Vej 7, 2100, Copenhagen Oe
Aarhus Universitetshospital
Blodsygdomme Klinik, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Turku University Hospital
NA, Hameentie 11, 20520, Turku
University Of Helsinki
Comprehensive Cancer Center, Department of Hematology, Haartmaninkatu 3, P. O. Box 400, Helsinki
Oulu University Hospital
NA, Kajaanintie 50, 90220, Oulu
Centre Hospitalier Universitaire De Toulouse
Hematology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Poitiers
Hematology and Cell Therapy, 2 Rue De La Miletrie, 86000, Poitiers
Hopital Saint Louis
Immuno-hematology, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire De Lille
Hematology, Rue Michel Polonowski, 59000, Lille
Universitaetsklinikum Tuebingen AöR
Abt. f. Innere Medizin II, Haematologie/Onkologie/Rheumatologie, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Medical Center - University Of Freiburg
Klinik für Innere Medizin I, Haematologie und Onkologie, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Universitaetsklinikum Regensburg AöR
Klinik und Poliklinik fuer Innere Medizin III, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Universitaetsklinikum Wuerzburg AöR
Med. Klinik und Poliklinik II, Abt. fuer Onkologie/Haematologie, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
III. Medizinische Klinik u. Poliklinik, Langenbeckstrasse 1, Oberstadt, Mainz
Universitaet Leipzig
Medizinische Klinik und Poliklinik I - Bereich Haematologie und Zelltherapie, Liebigstrasse 22, Zentrum-Suedost, Leipzig
University Medical Center Hamburg-Eppendorf
II. Medizinische Klinik und Poliklinik, Onkologie und Haematologie, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Heidelberg AöR
Med. Klinik und Poliklinik V, Haematologie/Onkologie, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Klinikum der Universitaet Muenchen AöR
Med. Klinik und Poliklinik III Haematologie/Onkologie, Marchioninistrasse 15, Hadern, Munich
Charite Universitaetsmedizin Berlin KöR
Med. Klinik m. Schwerpunkt Haematologie, Onkologie und Tumorimmunologie, Hindenburgdamm 30, Lichterfelde, Berlin
Technische Universitaet Dresden
Med. Klinik und Poliklinik 1, Haematologische Ambulanz MK1-A1, Fetscherstrasse 74, Johannstadt-Nord, Dresden
University General Hospital Attikon
2nd Dept of Internal Medicine, Rimini Street 1, 124 62, Athens
Alexandra Hospital
Department of Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
Geniko Nosokomeio Thessalonikis George Papanikolaou
Hematology Department, Exochi, 570 10, Thessaloniki
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Hematologiai es Ossejt-transzplantacios Osztaly, Albert Florian Ut 5-7, 1097, Budapest IX
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Hematologie, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Universitair Medisch Centrum Groningen
Hematologie, Hanzeplein 1, 9713 GZ, Groningen
Stichting Radboud universitair medisch centrum
Hematologie, P. O. Box 9101, 6500 HB, Nijmegen
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Transplantacji Szpiku i Onkohematologii, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Uniwersytecki Szpital Kliniczny W Poznaniu
Oddział Hematologii i Transplantaji Szpiku, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Oddzial Hematologii i Transplantacji Szpiku, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Instytut Hematologii I Transfuzjologii
Klinika Hematologii, Ul Indiry Gandhi 14, 02-776, Warsaw
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Hematology, Rua Professor Lima Basto, 1099-023, Lisbon
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Hematology, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
University Clinical Hospital Virgen De La Arrixaca
hematology, Carretera De Cartagena Sn, El Palmar, Murcia
University Hospital Virgen Del Rocio S.L.
Hematology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario 12 De Octubre
Hematology, Bloque D, Avenida De Cordoba Sn, Madrid
Clinica Universidad De Navarra
Hematologia, Avenue Pio XII 36, 31008, Pamplona
Hospital De La Santa Creu I Sant Pau
Hematology, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario Y Politecnico La Fe
Hematology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitari Vall D Hebron
Hematology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Marques De Valdecilla
Hematology, Avenida Valdecilla Sn, 39008, Santander
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital General Universitario Gregorio Maranon
Hematology, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2022-10-24 | 2022-10-25 | 2023-09-28 | ||
| Belgium | 2021-08-05 | 2021-09-09 | 2023-01-24 | ||
| Czechia | 2022-03-11 | 2022-03-15 | 2023-10-30 | ||
| Denmark | 2022-02-01 | 2022-03-14 | 2023-11-01 | ||
| Finland | 2022-03-24 | 2022-08-22 | 2023-10-17 | ||
| France | 2023-03-06 | 2023-04-18 | 2023-11-06 | ||
| Germany | 2022-01-31 | 2022-02-07 | 2023-11-02 | ||
| Greece | 2022-01-17 | 2022-01-24 | 2023-11-07 | ||
| Hungary | 2023-03-06 | 2023-08-01 | 2023-08-14 | ||
| Ireland | 2023-01-31 | 2023-04-21 | 2023-09-28 | ||
| Netherlands | 2022-03-10 | 2022-05-10 | 2023-11-20 | ||
| Norway | 2022-04-13 | 2022-05-04 | 2023-10-16 | ||
| Poland | 2021-10-29 | 2021-11-09 | 2023-10-30 | ||
| Portugal | 2022-10-18 | 2023-01-25 | 2023-11-03 | ||
| Spain | 2021-08-19 | 2021-08-19 | 2023-08-24 | ||
| Sweden | 2021-11-24 | 2021-12-06 | 2023-03-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 172 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_REDACTED Protocol 2023-505850-16 | Am4-EEA-2 |
| Protocol (for publication) | REDACTED__D4_PF MySLM-Q_SE_swe_2023-505850-16 | 1 |
| Protocol (for publication) | REDACTED_D4_MySIm-Q_GR_Gre_2023-505850-16-00 | 1 |
| Protocol (for publication) | REDACTED_D4_PF CTCAE_AT_GER_2023-505850-16 | 1 |
| Protocol (for publication) | REDACTED_D4_PF MySIm-Q_AT_GER_ 2023-505850-16 | 1 |
| Protocol (for publication) | REDACTED_D4_PF MySIm-Q_BE_Dut_2023-505850-16 | 1 |
| Protocol (for publication) | REDACTED_D4_PF MySIm-Q_BE_Fre_2023-505850-16 | 1 |
| Protocol (for publication) | REDACTED_D4_PF MySIm-Q_CZ_cze_2023-505850-16 | 1 |
| Protocol (for publication) | REDACTED_D4_PF MySIm-Q_DE_ger_ 2023-505850-16 | 1 |
| Protocol (for publication) | REDACTED_D4_PF MySIm-Q_ES_SPA_ 2023-505850-16 | 1 |
| Protocol (for publication) | REDACTED_D4_PF MySIm-Q_FI_fin_2023-505850-16 | 1 |
| Protocol (for publication) | REDACTED_D4_PF MySIm-Q_FR_FRE_2023-505850-16 | 1 |
| Protocol (for publication) | Redacted_D4_PF MySIm-Q_HU_HUN_2023-505850-16-00 | 1 |
| Protocol (for publication) | REDACTED_D4_PF MySIm-Q_PT_POR_ 2023-505850-16 | 1 |
| Protocol (for publication) | REDACTED_D4_PF NCI PRO-CTCAE_ES_SPA_2023-505850-16 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS_BE_Dut_2023-505850-16 | 2 |
| Protocol (for publication) | REDACTED_D4_PF PGIS_BE_Fre_2023-505850-16 | 2 |
| Protocol (for publication) | REDACTED_D4_PF PGIS_CZ_cze_2023-505850-16 | 2 |
| Protocol (for publication) | REDACTED_D4_PF PGIS_ES_SPA_2023-505850-16 | 2 |
| Protocol (for publication) | Redacted_D4_PF PGIS_HU_HUN_2023-505850-16 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PGIS_MM_AT_GER_2023-505850-16 | 2 |
| Protocol (for publication) | REDACTED_D4_PF PGIS_MM_DE_ger_ 2023-505850-16 | 2 |
| Protocol (for publication) | REDACTED_D4_PF PGIS_MM_FR_FRE_ 2023-505850-16 | 2 |
| Protocol (for publication) | REDACTED_D4_PF PGIS_PT_POR_2023-505850-16 | 2 |
| Protocol (for publication) | REDACTED_D4_PF PGIS-MM_SE_swe_2023-505850-16 | 2 |
| Protocol (for publication) | REDACTED_D4_PF PRO-CTCAE_BE_Dut_2023-505850-16 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PRO-CTCAE_BE_Fre_2023-505850-16 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PRO-CTCAE_CZ_cze_2023-505850-16 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Pro-ctcae_DE_ger_ 2023-505850-16 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Pro-ctcae_FR_FRE_2023-505850-16 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PRO-CTCAE_GR_Gre_2023-505850-16-00 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PRO-CTCAE_PT_POR_2023-505850-16 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PRO-CTCAE_SE_swe_2023-505850-16 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_ NCI PRO-CTCAE _FI_fin_2023-505850-16 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_EORTC-QLQ-C30_multicountry_multilingual | 1 |
| Protocol (for publication) | REDACTED_D4_PF_EQ-5D-5L_multicountry_multilingual | 1 |
| Protocol (for publication) | REDACTED_D4_PF_PGIS_MM_FI_fin_2023-505850-16 | 2 |
| Protocol (for publication) | REDACTED_D4_PGIS_MM_GRC_Gre_2023-505850-16-00 | 1 |
| Protocol (for publication) | Redacted_D4_PRO-CTCAE_HU_HUN_2023-505850-16-00 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder Document_Recruitment Arrangement_DE_ENG_68284528MMY3004 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder Recruitment Arrangements_ES_EN_68284528MMY3004 | 1 |
| Recruitment arrangements (for publication) | K1_PLACEHOLDER Recruitment Arrangements_FR_EN_68284528MMY3004 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arrangements_CZ_ENG_68284528MMY3004 | 1 |
| Recruitment arrangements (for publication) | K1_PLACEHOLDER_Recruitment Arrangements_DK_eng_68284528MMY3004 | 1 |
| Recruitment arrangements (for publication) | K1_PLACEHOLDER_Recruitment Arrangements_HU_ENG_68284528MMY3004 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment arrangements_PT_EN_68284528MMY3004 | 1 |
| Recruitment arrangements (for publication) | K1_PLACEHOLDER_Recruitment Arrangements_SE_eng_68284528MMY3004 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements Placeholder_PL_PL_ 68284528MMY3004 | 1 |
| Recruitment arrangements (for publication) | PLACEHOLDER K1_Recruitment Arrangements _AT_Eng_64468284528MMY3004 | 1 |
| Recruitment arrangements (for publication) | PLACEHOLDER K1_Recruitment Arrangements _FI_Eng_64468284528MMY3004 | 1 |
| Recruitment arrangements (for publication) | PLACEHOLDER K1_Recruitment Arrangements _GR_Eng_64468284528MMY3004 | 1 |
| Recruitment arrangements (for publication) | PLACEHOLDER K1_Recruitment Arrangements _IE_Eng_64468284528MMY3004 | 1 |
| Recruitment arrangements (for publication) | PLACEHOLDER K1_Recruitment Arrangements _NO_Eng_64468284528MMY3004 | 1 |
| Recruitment arrangements (for publication) | PLACEHOLDER K1_Recruitment Arrangements_BE_Eng_68284528MMY3004 | 1 |
| Recruitment arrangements (for publication) | PLACEHOLDER K1_Recruitment Arrangements_NL_Eng_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED L1_SIS and ICF Pregnant Partner_PT_PT_68284528MMY3004 | 3 |
| Subject information and informed consent form (for publication) | REDACTED L1_SIS and ICF Withdrawal ICF_PT_PT_68284528MMY3004 | 2 |
| Subject information and informed consent form (for publication) | Redacted_L1_Future Research ICF_IE_en_2023-505850-16-00 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 1_FR_FR_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum OOS_BE_Dut_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum OOS_BE_Eng_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum OOS_BE_Fre_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum_Consent_Form_PL_PL_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical Appendix_FI_fi_68284528MMY3004 | 13 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_DK_dan_2023-505850-16 | 11 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_ES_SPA_2023-505850-16 | 9 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_FI_fi_68284528MMY3004 | 13 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_NO_nor_2023-505850-16 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_PL_pol_2023-505850-16 | 10 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_PT_POR_2023-505850-16 | 13 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_SE_SWE_2023-505850-16 | 9 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Future Research_CZ_CZE_68284528MMY3004 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Genomic_Consent_Form_PL_PL_68284528MMY3004 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Genomic_FR_FR_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Genomic_ICF_HU_HU_68284528MMY3004 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main _GR_gre_2023-505850-16 | 9 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_BE_Dut_2023-505850-16 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_BE_Eng_68284528MMY3004 | 5.1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_BE_Fre_2023-505850-16 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_FR_FR_68284528MMY3004 | 10 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_Highlighted_CZ_CZE_68284528MMY3004 | 11 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_NL_Dut_2023-505850-16 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Compatible Research_DK_dan_68284528MMY3004 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF PP_FI_fi_68284528MMY3004 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF PP_GR_gre_68284528MMY3004 | 1.2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy Partner_AT_de_68284528MMY3004 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy_ES_ES_68284528MMY3004 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner ICF_NO_no_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_Consent_Form_PL_PL_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_CZ_CZE_68284528MMY3004 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_DK_dan_68284528MMY3004 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_FR_FR_68284528MMY3004 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_ICF_HU_HUN_2023-505850-16 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_SE_swe_2023-505850-16 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Language Pregnant Partner_CZ_CZE_68284528MMY3004 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Language_CZ_CZE_68284528MMY3004 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Language_Highlighted_CZ_CZE_68284528MMY3004 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Procedures and visits_Highlighted_CZ_CZE_68284528MMY3004 | 11 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_Consent_Form_PL_PL_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_ES_ES_68284528MMY3004 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Addendum OOS_NL_Dut_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Clinical main ICF_DE_GER_68284528MMY3004 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Country main ICF_AT_GER_2023-505850-16 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Future Research ICF_NO_no_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main ICF_HU_HUN_2023-505850-16 | 11 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main_IE_Eng_68284528MMY3004 | 7.1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_OoS ICF_DE_GER_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Optional further research ICF_DE_GER_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant partner consent form_DE_GER_68284528MMY3004 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant Partner_IE_Eng_68284528MMY3004 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Site Information Sheet_AT_GER_2023-505850-16 | 11 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Site Specific Clinical Main ICF Theurich_DE_GER_2023-505850-16 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Participation Card ARM A_FI_fi_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Participation Card Group A_ GR_gre_68284528MMY3004 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Participation Card Group B_GR_gre_68284528MMY3004 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Participation Card Pre-Rando Treatment Phase_FI_fi_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm A_BE_Dut_68284528MMY3004 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm A_BE_Fre_68284528MMY3004 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm B_BE_Dut_68284528MMY3004 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm B_BE_Fre_68284528MMY3004 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Pre-Randomization_BE_Dut_68284528MMY3004 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Pre-Randomization_BE_Fre_68284528MMY3004 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card - ArmA_DE_GER_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card - PreRando_DE_GER_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm A_AT_de_68284528MMY3004 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm A_CZ_CZE_68284528MMY3004 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm B_AT_de_68284528MMY3004 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm B_CZ_CZE_68284528MMY3004 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm B_DE_ger_2023-505850-16 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Group B_ES_SPA_2023-505850-16 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Group B_PT_POR_2023-505850-16 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Pre Randomization_AT_de_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Pre-randomisation_FR_FR_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Pre-Randomization_CZ_CZE_68284528MMY3004 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Pre-randomization_IE_Eng_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_Arm A_HU_HU_2023-505850-16 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_Arm A_NO_no_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_Arm A_PL_PL_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_Arm B_HU_HU_2023-505850-16 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_Arm B_NO_no_68284528MMY3004 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_Arm B_PL_PL_68284528MMY3004 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_Bras A_FR_FR_68284528MMY3004 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_Bras B_FR_FR_68284528MMY3004 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_Group A_IE_Eng_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_Group A_SE_Swe_2023-505850-16 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_Group B_SE_Swe_2023-505850-16 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_Group_B_FI_fin_2023-505850-16 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_Pre Randomization_HU_HU_68284528MMY3004 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_Pre Randomization_PL_PL_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_Pre-Randomization Treatment_NO_no_68284528MMY3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_SubjPartCard_Arm B_ IE_eng_2023-505850-16-00 | 5 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Dexamethason 4mg | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Dexamethasone 2mg | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Dexamethasone 2mg Merck | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Lenalidomide Accord | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Lenalidomide Mylan | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Velcade | NA |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis DK_Eng_ 2023-505850-16 | Am3 EEA-1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis FR_FRE_2023-505850-16 | Am4-EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_AT_GER_2023-505850-16 | Am4-EEA-2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_BE_Dut_2023-505850-16 | Am4-EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_BE_Fre_2023-505850-16 | Am4-EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_BE_Ger_2023-505850-16 | Am4-EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_CZ_cze_2023-505850-16 | Am4-EEA-2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_ES_SPA_2023-505850-16 | Am4 EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_GR_GRE_2023-505850-16 | Am4 EEA-2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_HU_HUN_2023-505850-16 | Am4-EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_NL_Dut_2023-505850-16 | Am4-EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_NO_nor_2023-505850-16 | Am4-EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_PL_POL_2023-505850-16 | Am4-EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_PT_POR_2023-505850-16 | Am4-EEA-2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_SE_Swe_2023-505850-16 | Am4-EEA2 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-05 | Belgium | Acceptable 2024-04-11
|
2024-04-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-23 | Belgium | Acceptable with conditions 2024-10-28
|
2024-10-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-13 | Acceptable with conditions | 2025-01-16 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-21 | Belgium | Acceptable 2025-05-26
|
2025-05-26 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-13 | Belgium | Acceptable 2025-09-01
|
2025-09-01 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-31 | Belgium | Acceptable 2026-01-12
|
2026-01-12 |