GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5

Sponsor
University of Heidelberg Medical Center
Study ID
NCT05695508
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Teclistamab (Tec) — DRUG
    Subcutaneous administration of Teclistamab
  • Daratumumab — DRUG
    Subcutaneous administration of Daratumumab
  • Dexamethasone — DRUG
    administered i.v. or orally
  • Lenalidomide — DRUG
    Administration oral
  • Bortezomib — DRUG
    Subcutaneous administration
  • Talquetamab — DRUG
    Subcutaneous administration of Daratumumab
  • JNJ-79635322 — DRUG
    Subcutaneous administration

Study Details

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

Key Dates

Start date
Dec 1, 2022
Status verified
Dec 2025
Primary completion
Sep 15, 2028
Completion
Sep 15, 2029

Study Design

Enrollment
160 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A Tec-DRd Induction and Tec-D Maintenance
    Arm A participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
  • Experimental: Arm B Tec-DVRd Induction and Tec-D Maintenance
    Arm B participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide, dexamethasone and bortezomib in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
  • Experimental: Arm C Tec-D Maintenance
    Arm C participants will receive maximum 18 cycles of teclistamab SC injection in combination with daratumumab SC and lenalidomide as maintenance therapy.
  • Experimental: Arm A1 Tec-DRd Induction and Tec-D Maintenance
    Arm A1 participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
  • Experimental: Arm C2 Tal-DR Maintenance
    Arm C2 participants will receive maximum 18 cycles of talquetamab SC injection in combination with daratumumab SC and lenalidomide as maintenance therapy.
  • Experimental: Arm D Tec-DRd Induction and Tec-Tal following induction
    Arm D participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by a combination of teclistamab and talquetamab SC injection in maximum 18 cycles of following induction therapy.
  • Experimental: Arm E Tal-DRd Induction and Tec-D Maintenance
    Arm E participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
  • Experimental: Arm E1 Tal-DRd Induction and Tal-D Maintenance
    Arm E1 participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by talquetamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
  • Experimental: Arm F Tal-DVRd Induction and Tec-D Maintenance
    Arm F participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, bortezomib, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
  • Experimental: Arm F1 Tal-DVRd Induction and Tal-D Maintenance
    Arm F1 participants will receive talquetamab as subcutaneous (SC) injection in combination with daratumumab SC, bortezomib, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by talquetamab SC injection in combination with daratumumab SC in maximum 18 cycles of maintenance therapy.
  • Experimental: Arm-G JNJ-79635322-DRd induction - JNJ-79635322-D following ind
    Arm G participants will receive six 28-day cycles of JNJ-79635322-DRd induction, followed byJNJ-79635322-D treatment for a maximum of eighteen 28-day cycles or until confirmed PD, death, intolerable toxicity, loss to follow-up, or consent withdrawal, whichever comes first. Tec-Tal or JNJ-79635322-D treatment can be discontinued when 12 months of sustained MRD negativity has been observed during the study.

Primary Outcome Measure

number of incidence and severity of adverse events [safety and tolerability] [ Time Frame: through study completion, up to 28 months ]

Central Contacts

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