Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
237
Countries
5
Sites
28
Multiple Myeloma
Compare MRD measurements by NGS (BM) and MS (M-protein in PB) at key timepoints in TE-NDMM participants combined across cohorts: • Cohort 1: Post-consolidation • Cohort 2: 3 cycles TEC-TAL • Cohort 3: 3 cycles JNJ-79635322-D • Cohort 4: 3 cycles JNJ-79635322-DR
Key facts
- Sponsor
- European Myeloma Network B.V., Emn Trial Office S.r.l. Impresa Sociale
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 4 Apr 2024 → ongoing
- Decision date (initial)
- 2023-11-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Janssen Research & Development, LLC
External identifiers
- EU CT number
- 2023-505221-14-00
- ClinicalTrials.gov
- NCT06189833
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacogenetic, Pharmacogenomic, Therapy, Diagnosis
Compare MRD measurements by NGS (BM) and MS (M-protein in PB) at key timepoints in TE-NDMM participants combined across cohorts:
• Cohort 1: Post-consolidation
• Cohort 2: 3 cycles TEC-TAL
• Cohort 3: 3 cycles JNJ-79635322-D
• Cohort 4: 3 cycles JNJ-79635322-DR
Secondary objectives 7
- Compare MRD by NGS (BM) and MS (M-protein in PB) at: Post-induction, combined across cohorts ( Cohort 1&2);6 cycles of D-VRd therapy, combined across cohorts (Cohort 2&3);12 cycles of TEC-TAL (Cohort 2); 12 cycles of JNJ-79635322-D( Cohort 3);6, 18 cycles of JNJ-79635322-DR( Cohort4);End of follow-up (Cohort 2,3&4)
- Compare MRD by NGF (BM) and MS (M-protein in PB) at the same timepoints as Secondary Objective 1, in addition to: • Post-consolidation (Cohort 1), following 3 cycles of TEC-TAL (Cohort 2), JNJ 79635322-D (Cohort 3), and JNJ-79635322-DR (Cohort 4), respectively, combined across cohorts
- Compare MRD by NGF (BM) and NGS (BM) at the same timepoints as Secondary Objective 2.
- Evaluate MRD-negativity rate with and without IMWG response achieved at any time up to: • Cohort 1: Post-consolidation • Cohort 2: 12 cycles TEC-TAL • Cohort 3: 12 cycles JNJ-79635322-D • Cohort 4: 18 cycles JNJ-79635322-DR
- Evaluate depth of response (the number and percentage of participants achieving ORR, VGPR or better, CR or better and sCR per IMWG criteria) at: • Cohort 1: Post-induction, post-transplant, and overall up to post consolidation. •Cohort 2: Post-induction, 6 cycles of D-VRd, 3 and 12 cycles TEC-TAL, and overall.• Cohort 3: Post-induction, 6 cycles of D-VRd, 3 and 12 cycles JNJ 79635322 D, and overall. • Cohort 4: 3, 6, and 18 cycles JNJ-79635322-DR, and overall.
- Evaluate the impact of cytogenetic abnormalities, R-ISS, CTCs on likelihood to develop MRD negative disease and agreement between the different techniques.
- Evaluate safety and tolerability of TEC-TAL (Cohort 2), JNJ-79635322-D (Cohort 3), and JNJ 79635322-DR (Cohort 4), respectively.
Conditions and MedDRA coding
Multiple Myeloma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10028228 | Multiple myeloma | 10029104 |
Study design 4 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening Screening phase begins when the ICF is signed. During the Screening Phase, eligibility criteria will be reviewed and a complete clinical evaluation will be performed as specified in the Schedule of Events (Table 29). Participants in Cohort 2 will be required to provide additional informed consent after completion of induction treatment. Screening procedures will be performed ≤28 days before approval; however, skeletal survey or other radiologic tests (eg., WB-LDCT, skeletal radiography, MRI or PET-CT) to document baseline lytic lesions or size of known or suspected extramedullary plasmacytomas ECG, multiple gated acquisition scan (MUGA), chest xrays or full dose chest CT scans, spirometry, or bone marrow aspirate/biopsy performed up to 6 weeks (42 days) before eligibility approval as routine standard of care for the participant’s disease can be used. Two negative pregnancy tests for females of childbearing potential must be documented at screening including one within 24 hours before the first dose of any component of the study treatment. Study treatment must begin within 7 days from Sponsor approval.
Participants who fail to meet the inclusion criteria or who fulfill any of the exclusion criteria (i.e., screen failures) may be rescreened once if their condition changes. Rescreening must be discussed with and approved by the sponsor on a case-by-case basis. Participants who are determined to be eligible for rescreening must sign a new ICF and then will be assigned a new screening number.
|
Not Applicable | None | ||
| 2 | Treatment Phase The Treatment Phase begins with the start of administration of D-VRd (Cohort 1, 2, and 3) or JNJ 79635322 DR (Cohort 4). The Treatment Phase continues until the completion of the EoT visit. Additional details of treatment received are summarized in Section 7.
|
Not Applicable | None | Part 1: Cohort 1 and 2. Part 2: Cohort 1: Part 1: Cohort 1 and 2 Cycles 1-4: Induction Treatment Participants will receive four 28-day cycles of induction therapy according to the dosing schedule specified in Table 4. Efficacy assessments will be performed according to Table 29 and sent to central labs. Mobilization and Harvesting of Stem Cells Stem cell mobilization should be performed ≤6 weeks after completion of Cycle 4 using local SoC. Sites should be prepared to utilize plerixafor in addition to standard agents such as cyclophosphamide and G-CSF to ensure adequate mobilization. Additional use of plerixafor is recommended if there is a suspicion of inadequate mobilization. The use of a second mobilization per local SoC or alternatively a BM harvest should occur to ensure adequate stem cell yield per institutional practice if the stem cell yield is deemed to be suboptimal per investigator discretion. Part 2: Cohort 1 Conditioning (Melphalan Off-study per SoC) Participants should proceed to conditioning ≤4 weeks after stem cell mobilization. Participants will receive melphalan 200 mg/m2 as conditioning therapy over a period of 24 to 48 hours prior to ASCT. Melphalan may be given at a lower dose of 140 mg/m2, per institutional standards (ie, renal insufficiency). Transplant (per SoC) There should be no more than 12 weeks between end of induction and transplant. Participants will have a single re-infusion of stem cells 24 to 48 hours after high-dose melphalan. Engraftment/Recovery Participants will be monitored for successful engraftment by means of hematopoietic reconstitution (defined as ANC ≥0.5 x 109/L and platelet count ≥20 x 109/L). Supportive therapy will be administered according to institutional standards. During the immediate post-transplant period (defined as the first day of high-dose melphalan administration to the day before C5D1), neutropenia and thrombocytopenia resulting from BM aplasia will not be recorded as AEs in the eCRF with the exception of failure to achieve adequate hematological values that are required to start consolidation. Only the following AEs, concomitant medications and procedures associated with these AEs have to be recorded in the eCRF during this period: • any evolution of an ongoing AE at the time of ASCT • any new AE related, or that appears to be related, to study drug • any new infection toxicity Grade 3 or higher • any new oral mucositis toxicity Grade 3 or higher Cycles 5-6: Consolidation Consolidation therapy should commence within 12 weeks of transplant when engraftment is complete and ANC ≥1.0 x 109/L and platelet count ≥75 x 109/L (see Table 17), and when in the opinion of the investigator the participant is fit enough to tolerate subsequent systemic therapy (30−60 days post-ASCT). For participants who are unable to tolerate consolidation therapy due to delayed hematopoietic recovery exceeding 12 weeks, participants may proceed to EoT upon discussion with the medical monitor. Study assessments will be performed according to Table 29 Part 2: Cohort 2: Cycles 5-6 Participants in Cohort 2 will be required to reconsent and start Cycle 5 no later than 2 months after completion of induction in Part 1. Participants will receive two 28-day cycles (Cycle 5 6) according to Table 4 and per the dosing schedule specified in Section 7.1.1. Study assessments will be performed according to Table 30. Cycles 7-18: TEC-TAL Therapy Participants will receive twelve 28-day cycles of TEC-TAL therapy (Cycle 7-18). TEC-TAL and any pretreatment medications will be administered according to the dosing schedule specified in Table 5. Pretreatment medications must be administered prior to all step-up doses and first treatment dose in Cycle 7. Cohort 3: Cycles 1-6 Participants in Cohort 3 will consent at screening. Participants will receive treatment as outlined in Table 4, followed by stem cell collection per Section 8.2. Study assessments will be performed according to Table 31. Cycles 7-18: JNJ-79635322-D Participants will receive twelve 28-day cycles of JNJ-79635322-D. JNJ 79635322, daratumumab, and any pretreatment medications will be administered according to the dosing schedule specified in Table 8 and per dosing instructions in Table 9. Study assessments will be performed according to Table 31. Cohort 4: Cycles 1-18: JNJ-79635322-DR Participants in Cohort 4 will receive a total of eighteen 28-day cycles of JNJ-79635322-DR. JNJ-79635322, daratumumab, lenalidomide, and any pretreatment medications will be administered according to the dosing schedule specified in Table 10 and per dosing instructions in Table 11. After 3 cycles of therapy, participants should proceed to conditioning followed by stem cell collection per Section 8.2. Participants will continue therapy for an additional 15 cycles, for a total of 18 cycles of JNJ 79635322-DR. Study assessments will be performed according to Table 32 |
|
| 3 | End of treatment End of treatment visit (Cohort 1 to 4)
Unless a participant withdraws consent for study treatment, or is lost to follow-up, an EoT visit should be performed 30 days after the last dose of any component of the study treatment (with a window of 7 additional days) or before the start of subsequent treatment, (whichever happens first). Every effort should be made to conduct the EoT visit before the participant starts subsequent therapy. If a participant is unable to return to the site for the EoT visit, then the participant should be contacted to collect AEs and concomitant therapies that occur ≤30 days after the last dose of any component of the study treatment.
|
Not Applicable | None | ||
| 4 | Follow-up Phase Follow-up Phase
The Follow-up Phase (Cohort 2, 3 and 4 only) starts after the EOT visit and will continue for 12 months or until SST, death, withdrawal of consent, loss to follow-up, or end of the study (Section 8.4), whichever occurs first. AEs will be followed up as described in Section 10.5. For participants in Cohort 2 3, and 4, disease evaluations should be performed by central labs every Q8W during the Follow-up Phase, as specified in the relevant Schedule of Events.
|
Not Applicable | None |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2025-522844-41-00 | IMPD-Q only application | Janssen Cilag International |
| 2022-502446-27-00 | A Phase 3 Randomized Study Comparing Talquetamab in Combination with Pomalidomide (Tal-P), Talquetamab in Combination with Teclistamab (Tal-Tec), and Investigator’s Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants with Relapsed or Refractory Myeloma who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide | Janssen - Cilag International |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 1. 18 to 70 years of age, inclusive.
- 6. Clinical laboratory values meeting the following criteria during screening and ≤3 days prior to receiving first study treatment dose: Adequate bone marrow function: a. Hemoglobin ≥7.5 g/dL (≥4.65 mmol/L; without prior red blood cell [RBC] transfusion ≤7 days before laboratory test; recombinant human erythropoietin use is permitted. b. Absolute neutrophil count (ANC) ≥1.0 x 10^9/L (prior growth factor support is permitted but must be without support for 7 days for G-CSF or GM-CSF or 14 days for pegylated-G-CSF); c. Platelet count ≥50 x 10^9/L if bone marrow is >50% involved in myeloma. Otherwise ≥75 x 10^9/L (without transfusion support or thrombopoietin receptor agonist ≤7 days before the laboratory test) Adequate liver function: a. Aspartate aminotransferase (AST) ≤2.5 x ULN (Upper Limit Normal); b. Alanine aminotransferase (ALT) ≤2.5 x ULN; c. Total bilirubin ≤1.5 x ULN (except in participants with congenital nonhemolytic hyperbilirubinemia, such as Gilbert syndrome, direct bilirubin ≤1.5 x ULN) Adequate renal function: a. Estimated creatinine clearance ≥30 mL/min. Creatinine clearance may be calculated using Cockcroft-Gault or a 24-hour urine collection. b. Corrected serum calcium ≤13.5 mg/dL (≤3.4 mmol/L); or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L).
- 2. Must have a new diagnosis of MM per IMWG criteria.
- 3. Measurable disease by central lab defined by any of the following: a. Serum monoclonal protein (M-protein) levels ≥0.5 g/dL or urine M-protein levels ≥ 200 mg/24 hours; b. Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) and abnormal serum immunoglobulin kappa/lambda FLC ratio.
- 4. Newly diagnosed and treatment-naïve participants for whom high-dose therapy and autologous stem cell transplantation is part of the intended treatment plan.
- 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
Exclusion criteria 7
- 1. Prior or current systemic therapy or ASCT for any plasma cell dyscrasia, with the exception of emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment.
- 2. History of allogenic stem cell transplantation or prior organ transplant requiring immunosuppressive therapy.
- 3. Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the NCI-CTCAE Version 5.
- 4. Participants will be excluded if they have any of the following: a. Any ongoing myelodysplastic syndrome or B cell malignancy (other than multiple myeloma) b. Any history of malignancy, other than multiple myeloma, which is considered at high risk of recurrence requiring systemic therapy c. Any active malignancy (ie, progressing or requiring treatment change in the last 24 months prior to enrollment) other than multiple myeloma. The only allowed exceptions are malignancies treated within the last 24 months that are considered cured: i. Non-muscle invasive bladder cancer (solitary Ta-papillary urothelial neoplasm of low malignant potential [PUNLMP] or low grade, <3 cm, no carcinoma in situ) ii. Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone iii. Noninvasive cervical cancer iv. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ or history of localized breast cancer (anti-hormonal therapy is permitted) v. Localized prostate cancer (M0, N0) with a Gleason Score ≤7 a, treated locally only (radical prostatectomy/radiation therapy/focal treatment) vi. Other malignancy that is considered cured with minimal risk of recurrence in consultation with the sponsor’s medical monitor NOTE: In the event of any questions, consult with the sponsor’s medical monitor prior to enrolling a participant.
- 5. Plasmapheresis ≤28 days of approval.
- 6. Radiation therapy for treatment of plasmacytoma ≤14 days of approval of enrollment (palliative radiation for pain control secondary to lytic lesion is allowed ≤14 days of approval).
- 7. Central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary and secondary endpoints, and their respective timepoints are defined in Table 33 of the Protocol
Secondary endpoints 2
- The primary and secondary endpoints, and their respective timepoints are defined in Table 33 of the Protocol
- Incidence and severity of AEs, adverse laboratory results, and other safety parameters following TEC-TAL, JNJ-79635322-D, and JNJ-79635322-DR administration.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 17
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 960 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 960 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dexamethasone Sodium Phosphate
SUB01615MIG · Substance
- Active substance
- Dexamethasone Sodium Phosphate
- Pharmaceutical form
- ORAL DROPS, SOLUTION
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 960 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 960 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lenalidomide Accord 10 mg hard capsules
PRD6773397 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 3150 mg milligram(s)
- Max treatment duration
- 12 Month(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
- No
Lenalidomide Accord 25 mg hard capsules
PRD6773401 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 3150 mg milligram(s)
- Max treatment duration
- 12 Month(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
- No
Lenalidomide Accord 15 mg hard capsules
PRD6773399 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 3150 mg milligram(s)
- Max treatment duration
- 12 Month(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
- No
Lenalidomide Accord 5 mg hard capsules
PRD6773394 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 3150 mg milligram(s)
- Max treatment duration
- 12 Month(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
- No
Lenalidomide Accord 20 mg hard capsules
PRD6773400 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 3150 mg milligram(s)
- Max treatment duration
- 12 Month(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
- No
DARZALEX 1800 mg solution for injection
PRD8157846 · Product
- Active substance
- Daratumumab
- Substance synonyms
- HuMax-CD38
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 1 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FC01 — -
- Marketing authorisation
- EU/1/16/1101/004
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/13/1153
- Modified vs. Marketing Authorisation
- No
PRD10228219 · Product
- Active substance
- IGG1 Trispecific Monoclonal Antibody Against T-Cell Receptor CD3, B-Cell Maturation Antigen and G Protein-Coupled Receptor Class C Group 5 Member D
- Substance synonyms
- IgG1 trispecific monoclonal antibody against CD3, BCMA and GPRC5D, JNJ-79635322
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg/ml milligram(s)/millilitre
- Max total dose
- 1 mg/ml milligram(s)/millilitre
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/25/3106
PRD10228220 · Product
- Active substance
- IGG1 Trispecific Monoclonal Antibody Against T-Cell Receptor CD3, B-Cell Maturation Antigen and G Protein-Coupled Receptor Class C Group 5 Member D
- Substance synonyms
- IgG1 trispecific monoclonal antibody against CD3, BCMA and GPRC5D, JNJ-79635322
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg/ml milligram(s)/millilitre
- Max total dose
- 1 mg/ml milligram(s)/millilitre
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/25/3106
PRD10381753 · Product
- Active substance
- Talquetamab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg/kg milligram(s)/kilogram
- Max total dose
- 1 mg/kg milligram(s)/kilogram
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10381752 · Product
- Active substance
- Talquetamab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg/kg milligram(s)/kilogram
- Max total dose
- 1 mg/kg milligram(s)/kilogram
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9936206 · Product
- Active substance
- Teclistamab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg/kg milligram(s)/kilogram
- Max total dose
- 1 mg/kg milligram(s)/kilogram
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9936207 · Product
- Active substance
- Teclistamab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg/kg milligram(s)/kilogram
- Max total dose
- 1 mg/kg milligram(s)/kilogram
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
VELCADE 3.5 mg powder for solution for injection
PRD703624 · Product
- Active substance
- Bortezomib
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 1.3 mg/m2 milligram(s)/square meter
- Max total dose
- 31.2 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Month(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
- No
Auxiliary 6
SUB07211MIG · Substance
- Active substance
- Diphenhydramine
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 800 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 960 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 960 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dexamethasone Sodium Phosphate
SUB01615MIG · Substance
- Active substance
- Dexamethasone Sodium Phosphate
- Pharmaceutical form
- ORAL DROPS, SOLUTION
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 960 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 960 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09611MIG · Substance
- Active substance
- Paracetamol
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 16000 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
European Myeloma Network B.V.
- Sponsor organisation
- European Myeloma Network B.V.
- Address
- Blaak 555
- City
- Rotterdam
- Postcode
- 3011 GB
- Country
- Netherlands
Scientific contact point
- Organisation
- European Myeloma Network B.V.
- Contact name
- Prof. Elena Zamagni
Public contact point
- Organisation
- European Myeloma Network B.V.
- Contact name
- Prof. Pieter Sonneveld
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other |
| EPL Pathology Archives LLC ORG-100042096
|
Leesburg, United States | Other |
| Clinigen Clinical Supplies Management ORG-100034422
|
Mont-Saint-Guibert, Belgium | Code 14 |
| Health Data Specialists S.r.l. ORG-100048392
|
Milan, Italy | On site monitoring, Code 11, Code 12, Code 13, Code 14, Other, Code 2, Interactive response technologies (IRT), Code 5, Data management, E-data capture, Code 8, Code 9 |
| Health Data Specialists Consulting Services Organization And Conduct Of Studies Single Member S.A. ORG-100042969
|
Athens, Greece | On site monitoring, Code 11, Code 12, Code 13, Code 14, Other, Code 2, Interactive response technologies (IRT), Code 5, Data management, E-data capture, Code 8, Code 9 |
| Emn Trial Office S.r.l. Impresa Sociale ORG-100032104
|
Turin, Italy | Laboratory analysis |
| Amsterdam UMC ORG-100008355
|
Amsterdam, Netherlands | Laboratory analysis |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) ORG-100008976
|
Rotterdam, Netherlands | Laboratory analysis |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Laboratory analysis |
| Sebia ORG-100046904
|
Evry-Courcouronnes, France | Laboratory analysis |
| Janssen Research And Development LLC ORG-100028792
|
Raritan, United States | Code 10, Code 11, Code 13, Code 14, Data management, Code 8 |
| The Binding Site Group Limited ORG-100046643
|
Birmingham, United Kingdom | Laboratory analysis |
Emn Trial Office S.r.l. Impresa Sociale
- Sponsor organisation
- Emn Trial Office S.r.l. Impresa Sociale
- Address
- Via Saluzzo 1/a, TO
- City
- Turin
- Postcode
- 10125
- Country
- Italy
Scientific contact point
- Organisation
- Emn Trial Office S.r.l. Impresa Sociale
- Contact name
- Prof. Mario Boccadoro
Public contact point
- Organisation
- Emn Trial Office S.r.l. Impresa Sociale
- Contact name
- Prof. Mario Boccadoro
Sponsor responsibilities
- Article 77 compliance
- European Myeloma Network B.V.
- Contact point sponsor
- European Myeloma Network B.V.
- Article 77 implementation
- European Myeloma Network B.V.
Locations
5 EU/EEA countries · 28 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 8 | 3 |
| Germany | Ongoing, recruiting | 5 | 2 |
| Greece | Ongoing, recruiting | 51 | 4 |
| Italy | Ongoing, recruiting | 170 | 13 |
| Netherlands | Ongoing, recruiting | 3 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Stadt Wien Wiener Gesundheitsverbund
Medical Department I - Center for Oncology, Hematology and Paliative Care, Montleartstrasse 37, Ottakring, Vienna
Medical University of Vienna
Department of Internal Medicine I - Division of Hematology and Hemostaseology, Waehringer Guertel 18-20, Alsergrund, Vienna
Ordensklinikum Linz GmbH
Hämatologie mit Stammzelltransplantation, Hämostaseologie und medizinische Onkologie, Fadingerstrasse 1, 4020, Linz
University Medical Center Hamburg-Eppendorf
Oncology, Hematology and Bone Marrow Transplantation with the Section Pneumology, Martinistrasse 52, Eppendorf, Hamburg
Klinikum rechts der Isar der TU Muenchen AöR
Internal Medicine III (Hematology/Oncology), Ismaninger Strasse 22, Au-Haidhausen, Munich
Theageneio Cancer Hospital
Hematology Anticancer Department, Papanastassiou Alexandrou 11, 546 39, Thessaloniki
St Savas Hospital
Department of Haematology Pathology Sector, Alexandras Avenue 171, 115 22, Athens
General Hospital Of Athens Alexandra
Department of Clinical Therapeutics, Vassilissis Sofias Avenue 80, 115 28, Athens
University General Hospital Of Alexandroupoli
University Hematology Clinic, 6th Km Alex Polis Makris, Dragana, Alexandroupoli
Azienda Unita Sanitaria Locale Della Romagna
Department of Onco-Hematology, Viale Luigi Settembrini 2, 47923, Rimini
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
UOC Haematology, Via Pietro Albertoni 15, 40138, Bologna
Careggi University Hospital
Heamtology Unit, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Casa Sollievo Della Sofferenza
Department of Haematology, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
IRCCS Ospedale Policlinico San Martino
UO Hematology, Largo Rosanna Benzi 10, 16132, Genoa
Azienda Ospedaliera Papa Giovanni XXIII
UOC Haematology, Piazza Oms 1, 24127, Bergamo
Azienda Sanitaria Universitaria Friuli Centrale
SOC Hematology Clinic, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Azienda Ospedaliero-Universitaria Maggiore Della Carita
SCDU Hematology, Corso Giuseppe Mazzini 18, 28100, Novara
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Department of Molecular Biotechnologies and Health Sciences, Via Cherasco 15, 10126, Turin
Azienda Ospedaliero Universitaria Delle Marche
SOD Hematology Clinic, Via Conca 71, 60126, Ancona
Fondazione IRCCS Policlinico San Matteo
UOC Haematology I, Viale Camillo Golgi 19, 27100, Pavia
Azienda USL IRCCS Di Reggio Emilia
Hematology Unit, Viale Risorgimento 80, 42123, Reggio Emilia
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
UOC Haematology, Piazzale Spedali Civili 1, 25123, Brescia
Rijnstate Ziekenhuis Stichting
Department of Haematology-Internal Medicine, Wagnerlaan 55, 6815 AD, Arnhem
Amsterdam UMC
Department of Haematology, De Boelelaan 1117, 1081 HV, Amsterdam
Amphia Hospital
Department of Haematology, Molengracht 21, 4818 CK, Breda
Dijklander Ziekenhuis
Department of Internal Medicine, Maelsonstraat 3, 1624 NP, Hoorn Nh
Universitair Medisch Centrum Groningen
Department of Haematology, Hanzeplein 1, 9713 GZ, Groningen
Maasstad Ziekenhuis Stichting
Department of Internal Medicine, Maasstadweg 21, 3079 DZ, Rotterdam
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 | 2023-12-18 | 2023-12-18 | |||
| Germany | 2026-02-25 | 2026-02-25 | |||
| Greece | 2024-02-02 | 2024-02-02 | |||
| Italy | 2023-12-04 | 2023-12-04 | |||
| Netherlands | 2024-04-04 | 2024-04-04 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 3 · Art. 38 CTR
Temporary halt TH-119747
- Halt date
- 2026-02-06
- Member states concerned
- Austria
- Publication date
- 2026-02-17
- Reason
- Sponsor decision
- Explanation
- Interruption of cohort 4 due to new data available; further details are provided in the attached letter.
- Follow-up measures
- Please refer to the attached letter signed by the Sponsor.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-119741
- Halt date
- 2026-02-06
- Member states concerned
- Italy
- Publication date
- 2026-02-17
- Reason
- Sponsor decision
- Explanation
- Interruption of cohort 4 due to new data available; further details are provided in the attached letter.
- Follow-up measures
- Please refer to the attached letter signed by the Sponsor.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-119744
- Halt date
- 2026-02-06
- Member states concerned
- Greece
- Publication date
- 2026-02-17
- Reason
- Sponsor decision
- Explanation
- Interruption of cohort 4 due to new data available; further details are provided in the attached letter.
- Follow-up measures
- Please refer to the attached letter signed by the Sponsor.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 91 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Statement for not redacted Protocol_EN | n/a |
| Protocol (for publication) | D1_Statement for not redacted Protocol_EN | n/a |
| Protocol (for publication) | D2_Protocol modification nr 6 2023-505221-14_EL_redacted | 6.0 |
| Protocol (for publication) | D2_Protocol modification nr 6 2023-505221-14_EN_redacted | 6.0 |
| Protocol (for publication) | D4_Patient Facing document Patient DiaryTeclistamab-AT | 1.0 |
| Protocol (for publication) | D4_Patient Facing document Patient DiaryTeclistamab-DE | 1.0 |
| Protocol (for publication) | D4_Patient Facing document Patient DiaryTeclistamab-EL | 1.0 |
| Protocol (for publication) | D4_Patient Facing document Patient DiaryTeclistamab-ENG | 1.0 |
| Protocol (for publication) | D4_Patient Facing document Patient DiaryTeclistamab-IT | 1.0 |
| Protocol (for publication) | D4_Patient Facing document Patient Temperature Diary_Cohort 3_4_AT | 1.0 |
| Protocol (for publication) | D4_Patient Facing document Patient Temperature Diary_Cohort 3_4_EN | 1.0 |
| Protocol (for publication) | D4_Patient Facing document Patient Temperature Diary_Cohort 3_4_IT | 1.0 |
| Protocol (for publication) | D4_Patient Facing document Patient Temperature Diary_Cohort 3_4_NL | 1.0 |
| Protocol (for publication) | D4_Patient Facing document Patient Temperature Diary_Cohort3_4_DE | 1.0 |
| Protocol (for publication) | D4_Patient Facing document Patient Temperature Diary_Cohort3_4_EL | 1.0 |
| Protocol (for publication) | D4_Patient Facing document-Patient Card-NL | 1.0 |
| Protocol (for publication) | D4_Patient Facing document-Patient Card-NL_1 | 1.0 |
| Protocol (for publication) | D4_Patient Facing document-Patient Diary Lenalidomide-AT | 1.0 |
| Protocol (for publication) | D4_Patient Facing document-Patient Diary Lenalidomide-DE | 1.0 |
| Protocol (for publication) | D4_Patient Facing document-Patient Diary Lenalidomide-EL | 1 |
| Protocol (for publication) | D4_Patient Facing document-Patient Diary Lenalidomide-ENG | 1.0 |
| Protocol (for publication) | D4_Patient Facing document-Patient Diary Lenalidomide-IT | 1.0 |
| Protocol (for publication) | D4_Patient Facing document-Patient Diary Lenalidomide-NL | 1.0 |
| Protocol (for publication) | D4_Patient Facing document-Patient Diary Teclistamab-NL | 1.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card Cohort 1_AT | 2.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card Cohort 1_DE | 2.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card Cohort 1_EL | 2.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card Cohort 1_EN | 2.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card Cohort 1_IT | 2.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card Cohort 2_AT | 3.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card Cohort 2_DE | 3.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card Cohort 2_EL | 3.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card Cohort 2_EN | 3.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card Cohort 2_IT | 3.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card Cohort 3_AT | 1.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card Cohort 3_DE | 1.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card Cohort 3_EL | 1.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card Cohort 3_EN | 1.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card Cohort 3_IT | 1.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card Cohort 4_AT | 1.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card Cohort 4_DE | 1.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card Cohort 4_EL | 1.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card Cohort 4_EN | 1.0 |
| Protocol (for publication) | D4_Patient facing documents Patient Card Cohort 4_IT | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_DE_EN | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_EL | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements-NL | 2.0 |
| Recruitment arrangements (for publication) | Recruitment Arrangements-IT_1 | 2.0 |
| Subject information and informed consent form (for publication) | L_Contact Data List_AT_EN | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Cohort 2_AT_DE_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Cohort 2_GR_EL_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Cohort 2_IT_IT_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Cohort 2_NL_NL_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Cohort 3_4_AT_DE_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Cohort 3_4_DE_DE_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Cohort 3_4_IT_IT_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_AT_DE_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_DE_DE_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_GR_EL_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_GR_EL_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP-PS_AT_DE_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP-PS_DE_DE_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP-PS_GR_EL_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP-PS_IT-IT_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP-PS_NL_NL_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Trispecific_GR_EL_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Cohort 2_DE_DE_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_IT_IT_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_NL_NL_redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_Statement for not redacted Main ICF_AT_EN | n/a |
| Subject information and informed consent form (for publication) | L1_Statement for not redacted Main ICF_DE_EN | n/a |
| Subject information and informed consent form (for publication) | L1_Statement for not redacted Main ICF_NL_EN | n/a |
| Subject information and informed consent form (for publication) | L1_Statement for not redacted Pregnancy ICF_AT_EN | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Dexamethasone 20 mg | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Dexamethasone_0_2_20mg | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Dexamethason 2mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Dexamethason 4mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Lenalidomide Accord- All Strenght | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Velcade_3-5 mg | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis 2023-505221-14_EN_Redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis AT 2023-505221-14_DE_redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis DE 2023-505221-14_DE_redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis GR 2023-505221-14_EL_Redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis IT 2023-505221-14_IT_Redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis NL 2023-505221-14_NL_Redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Statement for not redacted synopsis_EN | n/a |
| Synopsis of the protocol (for publication) | D1_Statement for not redacted synopsis_EN | n/a |
| Synopsis of the protocol (for publication) | D1_Statement for not redacted synopsis_EN | n/a |
| Synopsis of the protocol (for publication) | D1_Statement for not redacted synopsis_EN | n/a |
| Synopsis of the protocol (for publication) | D1_Statement for not redacted synopsis_EN | n/a |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-13 | Italy | Acceptable 2023-11-06
|
2023-11-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-17 | Acceptable | 2023-12-14 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-03 | Italy | Acceptable 2024-05-31
|
2024-06-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-07 | Italy | Acceptable 2025-05-20
|
2025-05-21 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-10 | Italy | Acceptable 2025-06-30
|
2025-07-01 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-09-26 | Italy | Acceptable 2026-01-19
|
2026-01-19 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-19 | Italy | Acceptable 2026-01-19
|
2026-02-19 |