Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
473
Countries
16
Sites
107
Relapsed/Refractory Multiple Myeloma
To compare the efficacy of elranatamab (Arm A) vs EPd or PVd or Kd (Arm B)
Key facts
- Sponsor
- Pfizer Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 27 May 2024 → ongoing
- Decision date (initial)
- 2024-05-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507871-23-00
- ClinicalTrials.gov
- NCT06152575
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenetic, Safety, Efficacy, Therapy, Pharmacokinetic, Others
To compare the efficacy of elranatamab (Arm A) vs EPd or PVd or Kd (Arm B)
Secondary objectives 6
- To compare the efficacy of elranatamab (Arm A) vs EPd or PVd or Kd (Arm B)
- To determine the safety and tolerability of elranatamab monotherapy
- To assess the safety and efficacy of elranatamab in US racial and ethnic minority participants
- To evaluate the PK of elranatamab
- To evaluate immunogenicity of elranatamab
- To evaluate the impact of treatment on participant HRQoL (health related quality of life)
Conditions and MedDRA coding
Relapsed/Refractory Multiple Myeloma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.0 | LLT | 10086466 | Relapsed/refractory multiple myeloma | 100000004848 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- EMA paediatric investigation plan (PIP)
- EMEA-003083-PIP01-21
- Plan to share IPD
- Yes
- IPD plan description
- Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations if ≥18) at screening.
- Prior diagnosis of MM (multiple myeloma) per IMWG criteria and previously received at least 1 but not more than 4 prior lines of therapy for MM including: • At least 2 consecutive cycles of an anti-CD38 antibody-containing regimen in any prior line AND • At least 2 consecutive cycles of a lenalidomide-containing regimen in any prior line
- Documented evidence of progressive disease or failure to achieve a response to last line of MM therapy based on investigator's determination of response by IMWG criteria.
- Measurable disease based on IMWG criteria as defined by at least 1 of the following (assessed by central laboratory): • Serum M-protein (myeloma protein) ≥0.5 g/dL; • Urinary M-protein excretion ≥200 mg/24 hours; • Serum involved immunoglobulin FLC (free light chain) ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
- Corrected serum calcium ≤14 mg/dL (≤3.5 mmol/L), or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L)
- Adequate bone marrow function (ANC, platelets, hemoglobin)
- ECOG (Eastern Cooperative Oncology Group) performance status <2.
Exclusion criteria 16
- Plasma cell leukemia, Smoldering MM, Waldenström’s macroglobulinemia, Amyloidosis, POEMS (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy and Skin abnormalities) Syndrome, known CNS (central nervous system) involvement or clinical signs of myelomatous meningeal involvement, stem cell transplant within 12 weeks prior to enrollment, active GVHD (graft versus host disease) (other than Grade 1 skin involvement) or GVHD requiring treatment.
- Active HBV (Hepatitis B virus), HCV (Hepatitis C virus), SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), HIV [human immunodeficiency virus], or any active, uncontrolled bacterial, fungal, or viral infection. Active infections must be resolved at least 21 days prior to enrollment. Treatment with systemic anti-infective agents must have completed at least 28 days prior to enrollment. Prophylactic use of systemic anti-infective agents is permitted.
- Ongoing Grade ≥3 peripheral sensory or motor neuropathy; history of GBS (Guillain-Barré syndrome) or GBS variants; history of any Grade ≥3 peripheral motor polyneuropathy.
- Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment, including LVEF (left ventricular ejection fraction) <40% as determined by a MUGA (multigated acquisition) scan or ECHO (echocardiogram) at screening.
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ or Stage 0/1 malignancy with minimal risk of recurrence per investigator
- Known or suspected hypersensitivity to the study interventions or any of their excipients.
- Unresolved acute effects (excluding alopecia) of any prior therapy (not resolved to baseline severity or CTCAE Grade ≤ 1).
- Previous treatment with a BCMA-directed or CD3 (cluster of differentiation 3) redirecting therapy.
- Individuals who have never achieved a response (partial response [PR] or better) with any treatment during the disease course.
- Unable to receive a control therapy (must be able and willing to adhere to any applicable requirements per Single Reference Safety Document [SRSD] for at least one choice of control therapy, including contraceptive requirements, and must not meet the exclusions listed below for the choice of control therapy): • unable to receive PVd if any of the following are present: • Received prior pomalidomide therapy • Does not meet criteria for bortezomib retreatment, (ie, must not have progressive disease during treatment or within 60 days of the last dose of a bortezomib-containing regimen) • Grade 1 peripheral neuropathy with pain or Grade ≥2 peripheral neuropathy as defined by NCI-CTCAE v5.0 • Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to enrollment • Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery (gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed, assuming no drug interaction potential). • unable to receive Kd if any of the following are present: • Received prior carfilzomib therapy • Uncontrolled hypertension • unable to receive EPd if any of the following are present: • Received prior pomalidomide therapy • Received prior elotuzumab therapy
- Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery (gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed, assuming no drug interaction potential).
- Live attenuated vaccines within 4 weeks of the first dose of study intervention;
- Cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone (≥21 mg of dexamethasone) within the 14-day period before the first dose of study intervention, and administered for reasons other than anti-myeloma therapy
- Anti-myeloma drug therapy, within 14 days of the initiation of study intervention (includes dexamethasone). Bisphosphonate use permitted.
- Impaired hepatic or renal function.
- Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PFS (progression free survival) by BICR (blinded independent central review) per IMWG (International Myeloma Working Group)
Secondary endpoints 7
- OS (overall survival)
- • PFS by Investigator per IMWG • PFS2 (PFS on next line therapy) by Investigator per IMWG • ORR (objective response rate) by BICR per IMWG • DOR (duration of response) by BICR per IMWG • VGPRR (very good partial response rate) (≥VGPR) (very good partial response) by BICR per IMWG • CRR (complete response rate) by BICR per IMWG • DOCR (duration of complete response) by BICR per IMWG • TTR (time to response) by BICR per IMWG
- • AEs (adverse events) • Laboratory abnormalities
- •PFS by BICR per IMWG •OS (overall survival) •PFS and PFS2 by Investigator per IMWG •ORR by BICR per IMWG • DOR by BICR per IMWG • VGPRR by BICR per IMWG •CRR by BICR per IMWG •DOCR by BICR per IMWG •TTR by BICR per IMWG •MRD negativity rate per IMWG •Sustained MRD negativity rate for at least 12 months per IMWG •AEs •Laboratory abnormalities
- Pre- and post-dose concentrations of elranatamab
- ADA (antidrug antibody) and NAb (neutralizing antibody) against elranatamab
- • Change from baseline EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Cancer Questionnaire 30) scores (global health, fatigue, pain, physical functioning, role functioning, and emotional functioning domains) • Change from baseline MY20 (multiple myeloma module quality of life questionnaire) scores (disease symptoms, side-effects of treatment, body image, and future perspective domains)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10297333 · Product
- Active substance
- Elranatamab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 76 mg milligram(s)
- Max total dose
- 5972 mg milligram(s)
- Max treatment duration
- 55 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- PFIZER INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 11
PRD9398498 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 8800 mg milligram(s)
- Max treatment duration
- 55 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- LT/1/21/4758/001
- MA holder
- NORAMEDA UAB
- MA country
- Lithuania
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD988426 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 8800 mg milligram(s)
- Max treatment duration
- 55 Month(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
- No
Dexamethason 0,5 mg JENAPHARM®
PRD988424 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 8800 mg milligram(s)
- Max treatment duration
- 55 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 3000402.00.00
- MA holder
- MIBE GMBH ARZNEIMITTEL
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9398502 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 8800 mg milligram(s)
- Max treatment duration
- 55 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 21-0051
- MA holder
- NORAMEDA UAB
- MA country
- Latvia
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bortezomib STADA 2,5 mg/ml Injektionslösung
PRD6601880 · Product
- Active substance
- Bortezomib
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS OR INTRAVENOUS
- Max daily dose
- 1.3 mg/m2 milligram(s)/sq. meter
- Max total dose
- 211 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 55 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XG01 — -
- Marketing authorisation
- 99063.00.00
- MA holder
- STADAPHARM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9260805 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 4620 mg milligram(s)
- Max treatment duration
- 55 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9260808 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 4620 mg milligram(s)
- Max treatment duration
- 55 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/004
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9260806 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 4620 mg milligram(s)
- Max treatment duration
- 55 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/003
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9260804 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 4620 mg milligram(s)
- Max treatment duration
- 55 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Empliciti 400 mg powder for concentrate for solution for infusion.
PRD4073310 · Product
- Active substance
- Elotuzumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 20 mg/kg milligram(s)/kilogram
- Max total dose
- 1120 mg/kg milligram(s)/kilogram
- Max treatment duration
- 55 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XC23 — -
- Marketing authorisation
- EU/1/16/1088/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kyprolis 60 mg powder for solution for infusion
PRD3374183 · Product
- Active substance
- Carfilzomib
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 123 mg milligram(s)
- Max total dose
- 40432 mg milligram(s)
- Max treatment duration
- 55 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XG02 — -
- Marketing authorisation
- EU/1/15/1060/001
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/08/548
- Modified vs. Marketing Authorisation
- No
Auxiliary 3
-
J06BA · Product
- Pharmaceutical form
- PHF00230MIG
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 2000 mg/Kg milligram(s)/kilogram
- Max total dose
- 110000 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J06BA — IMMUNOGLOBULINS, NORMAL HUMAN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Privigen 100 mg/ml solution for infusion
PRD339230 · Product
- Active substance
- Human Normal Immunoglobulin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 2000 mg/kg milligram(s)/kilogram
- Max total dose
- 110000 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J06BA02 — IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
- Marketing authorisation
- EU/1/08/446/005
- MA holder
- CSL BEHRING GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Privigen 100 mg/ml solution for infusion
PRD339233 · Product
- Active substance
- Human Normal Immunoglobulin
- Substance synonyms
- IMMUNOGLOBULIN HUMAN NORMAL
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 2000 mg/Kg milligram(s)/kilogram
- Max total dose
- 110000 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J06BA02 — IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
- Marketing authorisation
- EU/1/08/446/002
- MA holder
- CSL BEHRING GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pfizer Inc.
- Sponsor organisation
- Pfizer Inc.
- Address
- 66 Hudson Boulevard East
- City
- New York
- Postcode
- 10001-2189
- Country
- United States
Scientific contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Signant Health Global Solutions Limited ORG-100047290
|
Dublin 2, Ireland | Other |
| PPD Development LP ORG-100011560
|
Richmond, United States | Laboratory analysis |
| ICON Medical Imaging ORL-000001154
|
Blue Bell, United States | Other |
| Hematogenix Laboratory Services Limited ORG-100047188
|
Cheadle, United Kingdom | Laboratory analysis |
| Icon Laboratory Services Inc. ORG-100037135
|
Farmingdale, United States | Laboratory analysis |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Laboratory analysis |
| Personalis Inc. ORG-100043141
|
Fremont, United States | Laboratory analysis |
| WCG Clinical Inc. ORG-100040730
|
Princeton, United States | Other |
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Laboratory analysis |
Locations
16 EU/EEA countries · 107 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 20 | 8 |
| Croatia | Ongoing, recruiting | 21 | 7 |
| Czechia | Ongoing, recruiting | 26 | 4 |
| Denmark | Ongoing, recruiting | 12 | 3 |
| Finland | Ongoing, recruiting | 12 | 5 |
| France | Ongoing, recruiting | 59 | 17 |
| Germany | Ongoing, recruiting | 30 | 11 |
| Greece | Ongoing, recruiting | 40 | 6 |
| Italy | Ongoing, recruiting | 52 | 12 |
| Netherlands | Ongoing, recruiting | 17 | 3 |
| Norway | Ongoing, recruiting | 8 | 4 |
| Portugal | Ongoing, recruiting | 15 | 5 |
| Slovakia | Ongoing, recruiting | 15 | 5 |
| Slovenia | Authorised, recruiting | 6 | 2 |
| Spain | Ongoing, recruiting | 54 | 12 |
| Sweden | Ongoing, recruiting | 7 | 3 |
| Rest of world
United Kingdom, Canada, Argentina, Israel, Chile, Australia, Taiwan, Japan, Brazil, Korea, Republic of, United States
|
— | 79 | — |
Investigational sites
Algemeen Ziekenhuis Delta
NA, Deltalaan 1, 8800, Roeselare
Centre Hospitalier EPICURA
Hematology, Rue De Mons 63, 7301, Boussu
CHR Verviers
Onco-hematology, Rue Du Parc 29, 4800, Verviers
Grand Hopital De Charleroi
Oncology & Hematology, Rue Du Campus Des Viviers 1, 6060, Charleroi
UZ Brussel
Clinical Hematology, Laarbeeklaan 101, 1090, Jette
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Hematology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
Uz Gent
Hematology, Corneel Heymanslaan 10, 9000, Gent
Clinique Saint-Pierre
Oncology and Hematology, Avenue Reine Fabiola 9, 1340, Ottignies-Louvain-La-Neuve
University Hospital Centre Zagreb
Department of Internal Medicine, Division of hematology, Ulica Mije Kispatica 12, 10000, Zagreb
KBC Split
Department of hematology, Spinciceva 1, 21000, Split
Klinicki bolnicki centar Sestre milosrdnice
Department of hematology, Vinogradska Cesta 29, Zagreb, Grad Zagreb
Clinical Hospital Dubrava
Department of hematology, Avenija Gojka Suska 6, Zagreb, Grad Zagreb
Clinical Hospital Centre Rijeka
Department of hematology, Kresimirova 42, 51000, Rijeka
Klinicka bolnica Merkur
Department of Internal medicine, Ulica Ivana Zajca 19, 10000, Zagreb
Klinicki Bolnicki Centar Osijek
Department of hematology, Ulica Josipa Huttlera 4, 31000, Osijek
Fakultni Nemocnice Brno
Interní hematologická a onkologická klinika, Jihlavska 340/20, Bohunice, Brno
University Hospital Olomouc
Hemato-onkologická klinika, Zdravotniku 248/7, 779 00, Olomouc
Vseobecna Fakultni Nemocnice V Praze
1. interní klinika – hematologie, U Nemocnice 499/2, Nove Mesto, Prague 2
Fakultní Nemocnice Královské Vinohrady
Interní hematologická klinika, Srobarova 1150/50, Vinohrady, Prague 10
Rigshospitalet
Department of Haematology, Blegdamsvej 9, 2100, Copenhagen Oe
Aalborg University Hospital
Hematology, Hobrovej 18/22, 9000, Aalborg
Aarhus Universitetshospital
Department of Hematology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Kuopio University Hospital
N/A, Puijonlaaksontie 2, P. O. Box 1777, Kuopio
Oulu University Hospital
N/A, Kajaanintie 50, 90220, Oulu
HUS-Yhtymae
N/A, Haartmaninkatu 4, 00290, Helsinki
Turku University Hospital
Stem cell and hematology department, Hameentie 11, 20520, Turku
Tampere University Hospital
N/A, Elamanaukio 2, 33520, Tampere
Centre Hospitalier Intercommunal De Cornouaille
Haematology, 14 Avenue Yves Thepot, Bp 31757, Quimper Cedex
Centre Hospitalier Departemental Vendee
Onco-Haematology, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Centre Hospitalier Le Mans
Hematology, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
Centre Hospitalier De La Cote Basque
Hematology, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
CHRU De Nancy
Hematology, 11 Rue Du Morvan, Bp 80001, Vandoeuvre Les Nancy Cedex
Hopital NOVO
Hematology, 6 Avenue De L Ile De France, 95300, Pontoise
Hopital Haut Leveque
Hematology, Avenue Magellan, 33604, Pessac
Oncopole Claudius Regaud
Hematology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Bretagne Atlantique
Hematology and lmmunology, 20 Boulevard General Maurice Guillaudot, 56000, Vannes
Centre Hospitalier Universitaire De Poitiers
Service Hématologie et Thérapie cellulaire, PRC, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire De Nantes
Centre Régional de Traitement de l'Hémophilie, 1 Place Alexis Ricordeau, 44000, Nantes
Hopital Henri Mondor - 1 rue Gustave Eiffel
Hematology, Av du Mal de Lattre de Tassigny, 94000, Créteil
Hôpital Cochin
Haematology, 27 rue du Fbg St Jacques, 75014, Paris
CHU Bretonneau
Hematology and cell therapy, 2 boulevard Tonnelé, 37044, Tours
Centre Hospitalier Universitaire De Nice
Hematology, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier de Dunkerque
Hematology, 130 avenue Louis Herbeaux, France, Dunkerque
Hopital Necker Enfants Malades
Hematology, 149 Rue De Sevres, 75015, Paris
Medical Center - University Of Freiburg
Department of Internal Medicine I, Hematology, Oncology und Stem Cell Transplantation, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Diakonissen-Stiftungs-Krankenhaus Speyer gGmbH
n/a, Paul-Egell-Strasse 33, Sued, Speyer
Vivantes Netzwerk fuer Gesundheit GmbH
Hämatologie, Onkologie und Palliativmedizin, Dieffenbachstrasse 1/1, Kreuzberg, Berlin
Asklepios Kliniken Hamburg GmbH
Hämatologie, internistische Onkologie, Palliativmedizin und Rheumatologie, Paul-Ehrlich-Strasse 1, Othmarschen, Hamburg
St. Barbara-Klinik Hamm GmbH
Department of Hematology and Oncology, Am Heessener Wald 1, Heessen, Hamm
Klinikum Nuernberg
Klinik für Innere Medizin 5 Hämatologie und Onkologie, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
Universitaetsklinikum Bonn AöR
Medizinische Klinik III Gebäude A20, Venusberg-Campus 1, Venusberg, Bonn
Universitaetsklinikum Ulm AöR
Department of Internal Medicine Ill, Albert-Einstein-Allee 29, Eselsberg, Ulm
Universitaetsklinikum Jena KöR
Klinik für Innere Medizin II Abteilung Hämatologie und Internistische Onkologie, Am Klinikum 1, Lobeda, Jena
Robert Bosch Krankenhaus GmbH
N/A, Auerbachstrasse 110, Bad Cannstatt, Stuttgart
Medizinischen Universität Lausitz – Carl Thiem
2. Medizinische Klinik, Thiemstraße 111, 03048, Cottbus
University Hospital of Alexandroupolis
Hematology Clinic, Dragana Neas Makris, Eastern Makedonía kai Thrace, Alexandroupolis
University General Hospital Of Ioannina
Hematology Clinic, Niarchou Stavrou Avenue, 455 00, Ioannina
Theageneio Cancer Hospital
Hematology/Oncology Department, Simeonidi Alex 2, 546 39, Thessaloniki
Alexandra Hospital
Department of Clinical Therapeutics, Plasma cell dyscrasias unit, Vassilissas Sofias Avenue 80, 115 28, Athens
Evangelismos S.A.
Bone Marrow Transplantation Unit, Ipsiladou 45-47, 106 76, Athens
Geniko Nosokomeio Thessalonikis George Papanikolaou
Haematology Department, Exochi, 570 10, Thessaloniki
Careggi University Hospital
SOD Ematologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Istituto di Ematologia L. e A. Seragnoli, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliero Universitaria Delle Marche
Medicina Interna, SOD Clinica Ematologica, Via Conca 71, 60126, Ancona
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
U.O.Ematologia, Via Del Vespro 129, 90127, Palermo
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo
SSD di Onco-Ematologia, Ospedale San Carlo, Via Pio II 3, Milan
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Dipartimento di Oncologia, S.C. Ematologia Universitaria, Corso Bramante 88, 10126, Turin
Azienda Ospedaliero Universitaria Pisana
UO Ematologia, Via Roma 67, 56126, Pisa
European Institute Of Oncology S.r.l.
Hemato-oncology Division, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda Sanitaria Locale Di Pescara
Ematologia Clinica, Via Renato Paolini 47, 65124, Pescara
Azienda Socio Sanitaria Territoriale Ovest Milanese
Oncologia, Via Papa Giovanni Paolo II, 20025, Legnano
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
Hematology Unit, Via Antonio Di Rudini' 8, 20142, Milan
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
NA, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Albert Schweitzer Ziekenhuis
Department Internal Medicine, Albert Schweitzerplaats 25, 3318 AT, Dordrecht
University Hospital Maastricht
NA, P Debyelaan 25, 6229 HX, Maastricht
Vestfold Hospital Trust
Missing, P. O. Box 2168, 3103, Tonsberg
St. Olavs Hospital HF
Avdeling for blodsykdommer, P. O. Box 3250, Torgarden, Trondheim
Oslo University Hospital HF
Oslo Myeloma Center, Taarnbygget, Kirkeveien 166, Oslo
Akershus University Hospital
Hematologisk avdeling, Sykehusveien 25, 1474, Loerenskog
Unidade Local De Saude De Gaia/Espinho E.P.E.
Hematology, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Unidade Local De Saude De Coimbra E.P.E.
Hematology, Praceta Professor Mota Pinto, 3004-561, Coimbra
CCAB Centro Clinico Academico Braga Associacao
Hematology, Lugar De Sete Fontes S Victor, 4710-243, Braga
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Hematology, Rua Professor Lima Basto, 1099-023, Lisbon
Hospital Da Luz S.A.
Hematology, Avenida Lusiada 100, 1500-650, Lisbon
University Hospital Bratislava
Department of hematology and transfusiology, Antolska 11, Petrzalka, Bratislava
Univerzitna Nemocnica Martin
Department of Hematology and Transfusiology, Kollarova 2, 036 01, Martin
F D Roosevelt University General Hospital Of Banska Bystrica
Hematology Department, Namestie Ludvika Svobodu 1, 974 01, Banska Bystrica
Narodny Onkologicky Ustav
Department of Onco-hematology, Klenova 1, Nove Mesto, Bratislava
Univerzitna nemocnica L. Pasteura Kosice
Department of hematology and oncohematology, Trieda Snp 1, Zapad, Kosice - Zapad
University Medical Center Ljubljana
Clinical Department of Hematology, Japljeva Ulica 2, 1000, Ljubljana
Univerzitetni Klinicni Center Maribor
N/A, Ljubljanska Ulica 5, 2000, Maribor
Hospital Universitario Y Politecnico La Fe
Hematology Unit, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital General Universitario Gregorio Maranon
Hematology Unit, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Universitari Mutua Terrassa
Hematology Unit, Plaza del Dr. Robert 5, 08221, Terrassa
Hospital Clinic De Barcelona
Hematology Unit, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario De Cruces
Hematology Unit, Cruces Plaza S/n, 48903, Barakaldo
Hospital Universitario De Salamanca
Hematology Unit, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Regional De Malaga
Hematology Unit, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitario Infanta Leonor
Hematology Unit, Avenida Gran Via Del Este 80, 28031, Madrid
Institut Catala D'oncologia
Hematology Unit, Carretera Canyet S/n, 08916, Badalona
Hospital General Universitario Morales Meseguer
Hematology Unit, Avenida Del Marques De Los Velez S/n, 30008, Murcia
Hospital Universitario Hm Sanchinarro
Hematology Unit, Calle Ona 10, 28050, Madrid
Institut Catala D'oncologia
Hematology Unit, Avinguda De Franca S/n, 17007, Girona
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 |
|---|---|---|---|---|---|
| Belgium | 2024-06-17 | 2024-09-24 | |||
| Croatia | 2025-06-30 | 2025-07-15 | |||
| Czechia | 2024-06-20 | 2024-09-25 | |||
| Denmark | 2024-08-27 | 2024-10-22 | |||
| Finland | 2024-06-12 | 2024-07-15 | |||
| France | 2024-07-03 | 2024-07-31 | |||
| Germany | 2024-06-25 | 2024-09-16 | |||
| Greece | 2024-07-04 | 2024-10-14 | |||
| Italy | 2024-06-21 | 2024-08-07 | |||
| Netherlands | 2024-10-09 | 2024-11-18 | |||
| Norway | 2024-06-10 | 2024-06-12 | |||
| Portugal | 2025-06-27 | 2025-07-08 | |||
| Slovakia | 2025-06-20 | 2025-08-27 | |||
| Slovenia | 2025-09-16 | ||||
| Spain | 2024-05-27 | 2024-08-26 | |||
| Sweden | 2024-06-25 | 2024-11-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 225 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_PACL_2023 507871 23 00_C1071032_EN_Public | NA |
| Protocol (for publication) | D1_Protocol approval form_2023 507871 23 00_C1071032_EN_Public | Amd7 |
| Protocol (for publication) | D1_Protocol_2023 507871 23 00_C1071032_EN_Public | Amd7 |
| Protocol (for publication) | D1_Protocol_2023 507871 23 00_C1071032_GR_EL_Public | Amd7 |
| Protocol (for publication) | D4_1_1_EPd_Pom_Dex Dosing Diary C1 to C2_HR-HR_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_1_1_EPd_Pom_Dex Dosing Diary C1 to C2_PT-PT_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_1_1_EPd_Pom_Dex Dosing Diary C1 to C2_SK-SK_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_1_1_EPd_Pom_Dex Dosing Diary C1 to C2_SL-SL_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_1_EPd_Pom_Dex Dosing Diary C1 to C2_BECZDEDKESFIFRGRITNLNOSE_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_10_1_PGIC_HR-EN_C1071032_copyright | 1.0 |
| Protocol (for publication) | D4_10_PGIC_BECZDEDKESFIFRGRITNLNOSE_C1071032_copyright | 1.0 |
| Protocol (for publication) | D4_11_1_Slate Participant Facing Screen Report_BE_en_C1071032_copyright | 1 |
| Protocol (for publication) | D4_11_10_Slate Participant Facing Screen Report_FR_FR_C1071032_copyright | 1 |
| Protocol (for publication) | D4_11_11_Slate Participant Facing Screen Report_GR_EL_C1071032_copyright | 1 |
| Protocol (for publication) | D4_11_12_Slate Participant Facing Screen Report_IT_IT_C1071032_copyright | 1 |
| Protocol (for publication) | D4_11_13_Slate Participant Facing Screen Report_NL_NL_C1071032_copyright | 1 |
| Protocol (for publication) | D4_11_14_Slate Participant Facing Screen Report_NO_NO_C1071032_copyright | 1 |
| Protocol (for publication) | D4_11_15_Slate Participant Facing Screen Report_SE_SV_C1071032_copyright | 1 |
| Protocol (for publication) | D4_11_16_Slate Participant Facing Screen Report_HR-EN_C1071032_copyright | 1 |
| Protocol (for publication) | D4_11_2_Slate Participant Facing Screen Report_BE_FR_C1071032_copyright | 1 |
| Protocol (for publication) | D4_11_3_Slate Participant Facing Screen Report_BE_NL_C1071032_copyright | 1 |
| Protocol (for publication) | D4_11_4_Slate Participant Facing Screen Report_CZ_CS_C1071032_copyright | 1 |
| Protocol (for publication) | D4_11_5_Slate Participant Facing Screen Report_DE_DE_C1071032_copyright | 1 |
| Protocol (for publication) | D4_11_6_Slate Participant Facing Screen Report_DK_DK_C1071032_copyright | 1 |
| Protocol (for publication) | D4_11_7_Slate Participant Facing Screen Report_ES_ES_C1071032_copyright | 1 |
| Protocol (for publication) | D4_11_8_Slate Participant Facing Screen Report_FI_FI_C1071032_copyright | 1 |
| Protocol (for publication) | D4_11_9_Slate Participant Facing Screen Report_FI_SV_C1071032_copyright | 1 |
| Protocol (for publication) | D4_2_1_EPd_Pom_Dex Dosing Diary C3 plus_HR-HR_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_2_1_EPd_Pom_Dex Dosing Diary C3 plus_PT-PT_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_2_1_EPd_Pom_Dex Dosing Diary C3 plus_SK-SK_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_2_1_EPd_Pom_Dex Dosing Diary C3 plus_SL-SL_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_2_EPd_Pom_Dex Dosing Diary C3 plus_BECZDEDKESFIFRGRITNLNOSE_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_3_1_PVd_Pom_Dex Dosing Diary C1 to C8_HR-HR_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_3_1_PVd_Pom_Dex Dosing Diary C1 to C8_PT-PT_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_3_1_PVd_Pom_Dex Dosing Diary C1 to C8_SK-SK_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_3_1_PVd_Pom_Dex Dosing Diary C1 to C8_SL-SL_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_3_PVd_Pom_Dex Dosing Diary C1 to C8_BECZDEDKESFIFRGRITNLNOSE_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_4_1_PVd_Pom_Dex Dosing Diary C9 plus_HR-HR_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_4_1_PVd_Pom_Dex Dosing Diary C9 plus_PT-PT_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_4_1_PVd_Pom_Dex Dosing Diary C9 plus_SK-SK_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_4_1_PVd_Pom_Dex Dosing Diary C9 plus_SL-SL_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_4_PVd_Pom_Dex Dosing Diary C9 plus_BECZDEDKESFIFRGRITNLNOSE_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_5_1_Kd_Dex Dosing Diary_HR-HR_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_5_1_Kd_Dex Dosing Diary_PT-PT_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_5_1_Kd_Dex Dosing Diary_SK-SK_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_5_1_Kd_Dex Dosing Diary_SL-SL_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_5_Kd_Dex Dosing Diary_BECZDEDKESFIFRGRITNLNOSE_C1071032_Public | 4.0 |
| Protocol (for publication) | D4_6_1_EORTC QLQ C30_HR-EN_C1071032_copyright | 3.0 |
| Protocol (for publication) | D4_6_EORTC QLQ C30_BECZDEDKESFIFRGRITNLNOSE_C1071032_copyright | 3.0 |
| Protocol (for publication) | D4_7_1_EQ 5D 5L_BEDEDKESFIFRGRNLNOSE_C1071032_copyright | 1.0 |
| Protocol (for publication) | D4_7_2_EQ 5D 5L_CZ_IT_C1071032_copyright | 1.1 |
| Protocol (for publication) | D4_7_3_EQ 5D 5L_HR-EN_C1071032_copyright | 1.0 |
| Protocol (for publication) | D4_8_1_MY20_HR-EN_C1071032_copyright | NA |
| Protocol (for publication) | D4_8_1_MY20_SI-SI_C1071032_copyright | NA |
| Protocol (for publication) | D4_8_MY20_BECZDEDKESFIFRGRITNLNOSE_C1071032_copyright | 1 |
| Protocol (for publication) | D4_9_1_WPAI_FI_NL_C1071032_copyright | 2.0 |
| Protocol (for publication) | D4_9_2_WPAI_DE_DK_ES_FI_NO_SE_C1071032_copyright | 2.1 |
| Protocol (for publication) | D4_9_3_WPAI_FR_GR_C1071032_copyright | 2.2 |
| Protocol (for publication) | D4_9_4_WPAI_BE en_C1071032_copyright | 2.0 |
| Protocol (for publication) | D4_9_4_WPAI_BE fr nl_C1071032_copyright | 2.3 |
| Protocol (for publication) | D4_9_5_WPAI_IT_IT_C1071032_copyright | 2.4 |
| Protocol (for publication) | D4_9_6_WPAI_CZ_CS_C1071032_copyright | 2.6 |
| Protocol (for publication) | D4_9_7_WPAI_V2_6_HR-EN_C1071032_copyright | 2.0 |
| Recruitment arrangements (for publication) | K1 Recruitment and Informed Consent Procedure_C1071032_EN_public | N/A |
| Recruitment arrangements (for publication) | K1 Recruitment and Informed Consent Procedure_C1071032_FI_EN_public | 2 |
| Recruitment arrangements (for publication) | K1_C1071032_Recruitment and Informed Consent Procedure_DK_EN_Public | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment and Consent procedure_C1071032_FR_FR_Public | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedures_C1071032_SL_EN | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_C1071032_HR_EN_Public | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_C1071032_PT_EN | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_C1071032_SK_EN | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment-Consent procedure_IT_EN_Public | N/A |
| Recruitment arrangements (for publication) | K10 S955_SC_PFD_Study Brochure_Greece_C1071032_GR EL | 1 |
| Recruitment arrangements (for publication) | K1a_C1071032_Recruitment and Informed Consent Procedure_CZ_CS-EN_Public | 4 |
| Recruitment arrangements (for publication) | K1a_Recruitment and Consent procedure_C1071032_NO_EN_Public | N/A |
| Recruitment arrangements (for publication) | K1a_Recruitment and ICF procedure_C1071032_SWE_Public | 2.0 |
| Recruitment arrangements (for publication) | K1a_Recruitment Consent Procedure_C1071032_BE_EN_Public | N/A |
| Recruitment arrangements (for publication) | K1a_Recruitment-arrangements_C1071032_NL_Public | 4.0 |
| Recruitment arrangements (for publication) | K1a_Recruitment-Arrangements_EN_C1071032_Public | N/A |
| Recruitment arrangements (for publication) | K1a_Recrutment-consent-procedure_C1071032_DE_EN_Public | 2 |
| Recruitment arrangements (for publication) | K2 C1071032_MagnetisMM Program_Study Flyer_Public | V3 |
| Recruitment arrangements (for publication) | K2 MagnetisMM Program_Program-level Brochure_C1071032_GR EL | 3 |
| Recruitment arrangements (for publication) | K2_C1071032_Study Flyer_FR_Public | 3 |
| Recruitment arrangements (for publication) | K2_C1071032_Subject Recruitment_Study Flyer_CZ-CS_Public | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure insert_C1071032_PT_PT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Brochure insert_C1071032_HR_HR_Public | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Brochure insert_C1071032_SL_SL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Informed consent flipbook_C1071032_HR_HR_Public | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_MagnetisMM Program level Brochure_C1071032_HR_HR_Public | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Postcard_C1071032_HR_HR_Public | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Understanding Your Study Video_C1071032_HR_HR_Public | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Understanding Your Study Video_C1071032_US_EN_Public | 1 |
| Recruitment arrangements (for publication) | K2a_Recruitment Material_Informed consent flipbook_C1071032_PT_PT | 1 |
| Recruitment arrangements (for publication) | K2b_Recruitment Material_Postcard_C1071032_PT_PT | 1 |
| Recruitment arrangements (for publication) | K2c_Recruitment Material_Understanding Your Study Video_C1071032_PT_PT | 1 |
| Recruitment arrangements (for publication) | K2d_Recruitment Material_Understanding Your Study Video_C1071032_US_EN | 1 |
| Recruitment arrangements (for publication) | K2e_MagnetisMM Recruitment Material Program_Program-level Brochure_C1071032_PT_PT | 3 |
| Recruitment arrangements (for publication) | K3 C1071032_MagnetisMM Program_Clinic poster_Public | V3 |
| Recruitment arrangements (for publication) | K3 MagnetisMM Program_Clinic poster_C1071032_GR EL | 3 |
| Recruitment arrangements (for publication) | K3_C1071032_Subject Recruitment_Clinic Poster_CZ-CS_Public | 3 |
| Recruitment arrangements (for publication) | K3_Recruitment materials_Informed consent flipbook_C1071032_SL_SL | 1 |
| Recruitment arrangements (for publication) | K4 C1071032_MagnetisMM Program_Program-level Brochure_Public | V3 |
| Recruitment arrangements (for publication) | K4 MagnetisMM Program_Study flyer_C1071032_GR EL | 3 |
| Recruitment arrangements (for publication) | K4_C1071032_Subject Recruitment_Program Brochure_CZ-CS_Public | 3 |
| Recruitment arrangements (for publication) | K4_Recruitment materials_Postcard_C1071032_SL_SL | 1 |
| Recruitment arrangements (for publication) | K5 C1071032_Understanding Your Study Video_Public | V1 |
| Recruitment arrangements (for publication) | K5 Informed consent flipbook_C1071032_GR EL | 1 |
| Recruitment arrangements (for publication) | K5_C1071032_Pre-Consent_Informed Consent Flipbook_DK-DA_Public | 1 |
| Recruitment arrangements (for publication) | K5_C1071032_Subject Recruitment_Informed Consent Flipbook_CZ-CS_Public | 1 |
| Recruitment arrangements (for publication) | K5_Recruitment materials_Understanding Your Study Video_C1071032_SL_SL | 1 |
| Recruitment arrangements (for publication) | K5a_Understanding Your Study Video_ C1071032_IT_EN_Public | 1 |
| Recruitment arrangements (for publication) | K6 Brochure insert_C1071032_GR EL | 1 |
| Recruitment arrangements (for publication) | K6 C1071032_Postcard_Public | V1 |
| Recruitment arrangements (for publication) | K6_C1071032_Subject Recruitment_Brochure Insert_CZ-CS_Public | 1 |
| Recruitment arrangements (for publication) | K6_Recruitment materials_Understanding Your Study Video_C1071032_US_EN | 1 |
| Recruitment arrangements (for publication) | K7 C1071032_Brochure insert_Public | V1 |
| Recruitment arrangements (for publication) | K7 Postcard_C1071032_GR EL | 1 |
| Recruitment arrangements (for publication) | K7_C1071032_Subject Recruitment_Postcard with QR code to video_CZ-CS_Public | 1 |
| Recruitment arrangements (for publication) | K7_Recruitment materials_MagnetisMM Program_Program level Brochure_C1071032_SL_SL | 3 |
| Recruitment arrangements (for publication) | K8_1 Understanding Your Study Video_C1071032_GR EL | 1 |
| Recruitment arrangements (for publication) | K8_2 Understanding Your Study Video_US EN | 1 |
| Recruitment arrangements (for publication) | K8_C1071032_Subject Recruitment_Understanding Your Study Video_CZ-CS_Public | 1 |
| Recruitment arrangements (for publication) | K9 S955_SC_PFD_Email Comm_TR-ERR_C1071032_GR EL | 1 |
| Recruitment arrangements (for publication) | K9_C1071032_Study Video Layout as reference_US-EN_Public | N/A |
| Subject information and informed consent form (for publication) | L1 Main ICD Greece_C1071032_EL_public | 5.0 |
| Subject information and informed consent form (for publication) | L1_1_ICF Main_C1071032_ BE-EN_Public | N/A |
| Subject information and informed consent form (for publication) | L1_4_ICF Main_C1071032_ BE-FR_Public | N/A |
| Subject information and informed consent form (for publication) | L1_7_ICF Main_C1071032_ BE-NL_Public | N/A |
| Subject information and informed consent form (for publication) | L1_C1071032_Main ICD_CZ-CS_Public | 7 |
| Subject information and informed consent form (for publication) | L1_C1071032_Main ICF_DK-DA_Public | N/A |
| Subject information and informed consent form (for publication) | L1_ICD Main_C1071032_SL_SL_Public | N/A |
| Subject information and informed consent form (for publication) | L1_Main ICD Finland_C1071032_FI_FI_Public | N/A |
| Subject information and informed consent form (for publication) | L1_Main ICD_C1071032_IT_IT_Public | N/A |
| Subject information and informed consent form (for publication) | L1_Main_ICD_C1071032_NO_NO_Public | N/A |
| Subject information and informed consent form (for publication) | L10_ICF Addendum_C1071032_BE-EN_Public | N/A |
| Subject information and informed consent form (for publication) | L11_ICF Addendum_C1071032_BE-FR_Public | N/A |
| Subject information and informed consent form (for publication) | L12_ICF Addendum_C1071032_BE-NL_Public | N/A |
| Subject information and informed consent form (for publication) | L1a_Adult-16yo Model ICF_NLD_C1071032_Public | N/A |
| Subject information and informed consent form (for publication) | L1a_ICD Main _C1071032_SK_SK_Public | 2 |
| Subject information and informed consent form (for publication) | L1a_ICD Main_C1071032_HR_HR_Public | N/A |
| Subject information and informed consent form (for publication) | L1a_ICF Main_ES_C1071032_Public | N/A |
| Subject information and informed consent form (for publication) | L1a_ICF_PA7 Addendum_C1071032_SK_SK | 1 |
| Subject information and informed consent form (for publication) | L1a_Main ICD_C1071032_DE_DE_Public | N/A |
| Subject information and informed consent form (for publication) | L1a_Main ICD_C1071032_FR_FR_Public | N/A |
| Subject information and informed consent form (for publication) | L1a_Main ICF_C1071032_SWE_Public | N/A |
| Subject information and informed consent form (for publication) | L1a_Main Model ICD_C1071032_PT_EN_Public | N/A |
| Subject information and informed consent form (for publication) | L1a_Main Model ICD_C1071032_PT_PT_Public | N/A |
| Subject information and informed consent form (for publication) | L1a_PA7 Addendum ICD_ C1071032_HR_HR | N/A |
| Subject information and informed consent form (for publication) | L1a_PA7 Addendum ICD_ C1071032_PT_PT | N/A |
| Subject information and informed consent form (for publication) | L1a_PA7 Addendum ICD_ C1071032_SL_SL | N/A |
| Subject information and informed consent form (for publication) | L1b_ICD Optional RRS_C1071032_SK_SK_Public | 1 |
| Subject information and informed consent form (for publication) | L1b_ICD Optional_C1071032_HR_HR_Public | 1 |
| Subject information and informed consent form (for publication) | L1b_Optional Model ICD_C1071032_PT_EN | N/A |
| Subject information and informed consent form (for publication) | L1b_Optional Model ICD_C1071032_PT_PT_Public | 1 |
| Subject information and informed consent form (for publication) | L1b_PA7 Addendum ICD_ C1071032_PT_PT_TC | N/A |
| Subject information and informed consent form (for publication) | L1c_ICD PPRIF_C1071032_SK_SK_Public | 3 |
| Subject information and informed consent form (for publication) | L1c_ICD PPRiF_C1071032_SK_SK_TC | 3 |
| Subject information and informed consent form (for publication) | L1c_ICD Pregnant Partner Release of Information Form_C1071032_HR_HR_Public | N/A |
| Subject information and informed consent form (for publication) | L1d_EU Privacy Notice_C1071032_SK_SK_Public | 1 |
| Subject information and informed consent form (for publication) | L1e_ICD Scout _C1071032_SK_SK | 1 |
| Subject information and informed consent form (for publication) | L2 Optional RRS FInland_C1071032_FI_public | N/A |
| Subject information and informed consent form (for publication) | L2 Pregnant Partner Release of Information Form_C1071032_EL_public | 1 |
| Subject information and informed consent form (for publication) | L2_2_ICD Optional Procedure_C1071032_SL_SL_Public | 1 |
| Subject information and informed consent form (for publication) | L2_C1071032_PPRIF_CZ-CS_Public | 2 |
| Subject information and informed consent form (for publication) | L2_C1071032_PPRIF_FR_Public | 1_1_1 |
| Subject information and informed consent form (for publication) | L2_C1071032_Pregnant Partner ICD_DK-DA_Public | 1.1 |
| Subject information and informed consent form (for publication) | L2_PPRIF_ES_C1071032_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_Pregnant Partner Model ICD_C1071032_PT_EN | N/A |
| Subject information and informed consent form (for publication) | L2_Pregnant Partner Model ICD_C1071032_PT_PT_Public | 1 |
| Subject information and informed consent form (for publication) | L2a C1071032_PPRIF_DEU_de_DE_Public | NA |
| Subject information and informed consent form (for publication) | L2a_Optional retained research samples ICF_SWE_C1071032_Public | NA |
| Subject information and informed consent form (for publication) | L2a_SIS-ICF Pregnancy_NLD_C1071032_Public | 3 |
| Subject information and informed consent form (for publication) | L3 C1071032_Country PPRIF_Public | N/A |
| Subject information and informed consent form (for publication) | L3 C1071032_Optional_RRS_ICD_Public | N/A |
| Subject information and informed consent form (for publication) | L3 EU Privacy Supplement Finland_C1071032_FI_public | N/A |
| Subject information and informed consent form (for publication) | L3 SC ICD Greece_C1071032_EL_public | 1 |
| Subject information and informed consent form (for publication) | L3_2_Pregnant Partner Release of Information Form_C1071032_SL_SL_Public | 1 |
| Subject information and informed consent form (for publication) | L3_Addendum ICD_C1071032_FR_FR_Public | N/A |
| Subject information and informed consent form (for publication) | L3_C1071032_Optional retained research sample ICD_CZ-CS_Public | 2 |
| Subject information and informed consent form (for publication) | L3_ICF Addendum_NLD_C1071032_Public | N/A |
| Subject information and informed consent form (for publication) | L3_ICF Optional Retained Research Samples_ES_C1071032_Public | 1 |
| Subject information and informed consent form (for publication) | L3a C1071032_Pfizer_German AKEK Optional Sample Collection ICD_DE_Public | NA |
| Subject information and informed consent form (for publication) | L3a_C1071032_Addendum ICF_DK_DA_public | 2 |
| Subject information and informed consent form (for publication) | L3a_Pregnant Partner Model ICF_SWE_C1071032_Public | NA |
| Subject information and informed consent form (for publication) | L4 C1071032_Pregnant_Partner_Release_of_Information_Form_Public | N/A |
| Subject information and informed consent form (for publication) | L4 C1071032_Privacy supplement_Public | N/A |
| Subject information and informed consent form (for publication) | L4 Pregnant Partner Release of Information Form Finland_C1071032_FI_public | N/A |
| Subject information and informed consent form (for publication) | L4_ ICD Addendum_C1071032_public | N/A |
| Subject information and informed consent form (for publication) | L4_Addendum ICD_C1071032_DE_DE_Public | N/A |
| Subject information and informed consent form (for publication) | L4_C1071032_EU Privacy Supplement Notice_CZ-CS_Public | 1 |
| Subject information and informed consent form (for publication) | L4_ICF_Addendum_ES_C1071032_Public | N/A |
| Subject information and informed consent form (for publication) | L4a_ICF Scout_C1071032_ BE-EN_Public | 4 |
| Subject information and informed consent form (for publication) | L4a_SC_ICD_C1071032_SWE_Public | 2.0 |
| Subject information and informed consent form (for publication) | L5_Addendum ICD_C1071032 _FI_FI_Public | N/A |
| Subject information and informed consent form (for publication) | L5_C1071032_SCOUT ICD_CZ-CS_Public | 1 |
| Subject information and informed consent form (for publication) | L5_ICF Addendum_C1071032_SWE_Public | n/a |
| Subject information and informed consent form (for publication) | L5a_Addendum ICD_C1071032 _NO_NO_Public | N/A |
| Subject information and informed consent form (for publication) | L5a_Addendum ICD_C1071032_IT_IT_Public | N/A |
| Subject information and informed consent form (for publication) | L5a_ICF Scout_C1071032_ BE-FR_Public | 3 |
| Subject information and informed consent form (for publication) | L6_C1071032_ICD Addendum_CZ-CS_public | 1 |
| Subject information and informed consent form (for publication) | L6a_ICF Scout_C1071032_ BE-NL_Public | 3 |
| Subject information and informed consent form (for publication) | L7a_ICF PPRIF_C1071032_ BE-EN_Public | 2 |
| Subject information and informed consent form (for publication) | L8a_ICF PPRIF_C1071032_ BE-FR_Public | 2 |
| Subject information and informed consent form (for publication) | L9a_ICF PPRIF_C1071032_ BE-NL_Public | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_1_SmPC Bortezomib_EN_C1071032_Public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_2_SmPC Carfilzomib_EN_C1071032_Public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_3_SmPC Dexamethasone_EN_C1071032_Public | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_4_SmPC Elotuzumab_EN_C1071032_Public | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_5_SmPC Pomalidomide_EN_C1071032_Public | 1 |
| Synopsis of the protocol (for publication) | D2_Protocol Synopsis_2023 507871 23 00_C1071032_EN_Public | Amd7 |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_2023 507871 23 00_C1071032_BE_DE_Public | Amd7 |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_2023 507871 23 00_C1071032_BE_FR_Public | Amd7 |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_2023 507871 23 00_C1071032_BE_NL_Public | Amd7 |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_2023 507871 23 00_C1071032_CZ_CS_Public | Amd7 |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_2023 507871 23 00_C1071032_DK_DA_Public | Amd7 |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_2023 507871 23 00_C1071032_ES_ES_Public | Amd7 |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_2023 507871 23 00_C1071032_FR_FR_Public | Amd7 |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_2023 507871 23 00_C1071032_GR_EL_Public | Amd7 |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_2023 507871 23 00_C1071032_IT_IT_Public | Amd7 |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_2023 507871 23 00_C1071032_NL_NL_Public | Amd7 |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_2023 507871 23 00_C1071032_NO_NO_Public | Amd7 |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_2023 507871 23 00_C1071032_PT-PT_Public | Amd7 |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_2023 507871 23 00_C1071032_SE_SV_Public | Amd7 |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_2023 507871 23 00_C1071032_SI-SI_Public | Amd7 |
| Synopsis of the protocol (for publication) | D3_Protocol Synopsis_2023 507871 23 00_C1071032_SK-SK_Public | Amd7 |
Application history
19 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-15 | Finland | Acceptable 2024-05-06
|
2024-05-06 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-15 | Finland | Acceptable 2024-05-06
|
2024-05-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-06 | Finland | Acceptable 2024-08-27
|
2024-08-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-10 | Finland | Acceptable 2025-01-28
|
2025-01-28 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-02-07 | Finland | Acceptable 2025-01-28
|
2025-02-07 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-02-07 | Finland | Acceptable 2025-01-28
|
2025-02-07 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-02-19 | Acceptable 2025-01-28
|
2025-02-19 | |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2025-02-28 | Acceptable 2025-01-28
|
2025-05-26 | |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2025-02-28 | 2025-03-31 | ||
| 10 | SUBSEQUENT ADDITION OF MSC | APP-10 | 2025-02-28 | Acceptable 2025-01-28
|
2025-04-17 | |
| 11 | SUBSEQUENT ADDITION OF MSC | APP-11 | 2025-02-28 | 2025-05-05 | ||
| 12 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-06 | Acceptable | 2025-04-18 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-07 | Acceptable | 2025-05-15 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-06-19 | Finland | Acceptable 2025-09-23
|
2025-09-23 |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-10-07 | Acceptable 2025-09-23
|
2025-10-07 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-10-24 | Acceptable | 2025-11-25 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-11-26 | Acceptable | 2026-02-03 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-01-09 | Acceptable | 2026-01-27 | |
| 19 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-01-16 | Acceptable | 2026-02-16 |