Actively Recruiting
GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5
Led by University of Heidelberg Medical Center · Updated on 2025-12-24
160
Participants Needed
11
Research Sites
354 weeks
Total Duration
On this page
Sponsors
U
University of Heidelberg Medical Center
Lead Sponsor
J
Janssen Research & Development, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Phase 2 Study to Evaluate Safety and Efficacy of Teclistamab-, Talquetamab-, and JNJ-79635322-based Combination Regimens in Participants with Newly Diagnosed Transplant Eligible Multiple Myeloma OBJECTIVES: To evaluate the safety and tolerability of teclistamab-, talquetamab-, and JNJ-79635322-based combination regimens over the entire treatment phase for each arm, in participants with ND-TEMM To evaluate the efficacy of teclistamab- and talquetamab-based combination regimens as induction and post-transplant maintenance treatments; JNJ-79635322-based combinations as induction and as replacement for HDT+ASCT following induction; and teclistamab in combination with talquetamab
CONDITIONS
Official Title
GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years, inclusive
- ECOG performance status score of 0 to 2 at screening and before starting treatment
- Documented multiple myeloma diagnosis following IMWG criteria
- Measurable disease defined by serum M-protein ≥1.0 g/dL, urine M-protein ≥200 mg/24 hours, or abnormal serum free light chain levels
- Newly diagnosed participants planned for high-dose therapy and autologous stem cell transplant (except Arms D and G)
- For Arms C and C2: received 4 to 6 cycles of induction therapy including a proteasome inhibitor and/or IMiD with or without anti-CD38 antibody, plus single or tandem ASCT
- Achieved at least partial response after one line of therapy for Arms C and C2
- Received ASCT within 12 months of induction start and within 6 months of last ASCT (7 months if consolidation therapy given)
You will not qualify if you...
- Central nervous system involvement or signs of meningeal multiple myeloma
- Stroke or seizure within 6 months before study start
- History of transplantations requiring immunosuppressive therapy
- Positive for HIV, hepatitis B, or active hepatitis C infection
- Chronic obstructive pulmonary disease with FEV1 below 50% predicted
- Moderate or severe persistent asthma in past 2 years or uncontrolled asthma with FEV1 below 50% predicted
- Medical or psychiatric conditions interfering with study or posing hazard
- Allergies or intolerances to study drugs or their components
- Pregnant, breastfeeding, or planning pregnancy during or within 6 months after treatment
- Planning to father a child during or within 100 days after treatment
- Prior systemic therapy or stem cell transplant for plasma cell disorders except short corticosteroid use (Arms A, A1, B, D, E, E1, F, F1)
- Peripheral neuropathy Grade 2 or higher (Arm B only)
- Use of strong CYP3A4 inducers within 5 half-lives before enrollment
- Discontinued lenalidomide due to adverse events (Arms C and C2)
- Disease progression on multiple myeloma therapy before screening (Arms C and C2)
- Received corticosteroids equivalent to ≥40 mg dexamethasone within 14 days before treatment start (Arms C and C2)
- Intolerance to starting dose of lenalidomide (10 mg) (Arms C and C2)
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Charité University Medicin Berlin
Berlin, Germany, 12203
Actively Recruiting
2
Clinic Chemnitz gGmbH
Chemnitz, Germany, 09113
Actively Recruiting
3
University Clinic Technical University Dresden
Dresden, Germany, 01307
Actively Recruiting
4
University Clinic Düsseldorf
Düsseldorf, Germany, 40225
Actively Recruiting
5
University Clinic Freiburg
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
6
Hamburg University Clinic Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
7
Asklepios Clinic Hamburg Altona
Hamburg, Germany, 22763
Actively Recruiting
8
University Hospital Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
9
University Clinic Schleswig-Holstein Campus Kiel
Kiel, Germany, 24105
Actively Recruiting
10
Technical University Munich
Munich, Germany, 81675
Actively Recruiting
11
University Würzburg
Würzburg, Germany
Actively Recruiting
Research Team
M
Marc S Raab, Prof. Dr. med
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
11
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