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

ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Heidelberg Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have an ECOG performance status score of 0 to 2 at screening

Have an ECOG performance status score of 0 to 2 at screening and immediately prior to the start of administration of study treatment

Multiple myeloma diagnosis according to the IMWG diagnostic criteria

Newly diagnosed multiple myeloma according to IMWG criteria.

Disqualifiers

Prior or current systemic therapy or stem cell transplant 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.

Arm B only: Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by the NCI-CTCAE Version 5.

Progressed on multiple myeloma therapy at any time prior to screening.

Received a cumulative dose of corticosteroids equivalent to ≥40 mg of dexamethasone within the 14 day period before the start of study treatment administration.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

160 Participants
are divided into 11 treatment groups

11

Treatment groups

See each treatment group below.

Group A: Arm A Tec-DRd Induction and Tec-D MaintenanceExperimental treatment 4 interventions
Group B: Arm B Tec-DVRd Induction and Tec-D MaintenanceExperimental treatment 5 interventions
Group C: Arm C Tec-D MaintenanceExperimental treatment 2 interventions
Group D: Arm A1 Tec-DRd Induction and Tec-D MaintenanceExperimental treatment 4 interventions
Group E: Arm C2 Tal-DR MaintenanceExperimental treatment 3 interventions
Group F: Arm D Tec-DRd Induction and Tec-Tal following inductionExperimental treatment 5 interventions
Group G: Arm E Tal-DRd Induction and Tec-D MaintenanceExperimental treatment 5 interventions
Group H: Arm E1 Tal-DRd Induction and Tal-D MaintenanceExperimental treatment 4 interventions
Group I: Arm F Tal-DVRd Induction and Tec-D MaintenanceExperimental treatment 6 interventions
Group J: Arm F1 Tal-DVRd Induction and Tal-D MaintenanceExperimental treatment 5 interventions
Group K: Arm-G JNJ-79635322-DRd induction - JNJ-79635322-D following indExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

number of incidence and severity of adverse events [safety and tolerability]

Time frame
through study completion, up to 28 months

Secondary outcomes

1

MRD negativity rate

MRD negativity rate measured by Flow Cytometry

Time frame
after 6 cycles (each cycle is 28 days) induction therapy (app.month 6), after High Dose Therapy (app. month 10), after 18 cycles (each cycle is 28 days) of maintenance therapy (app. month 28)
2

Response on therapy [efficacy]

Response on therapy according to IMWG: * Overall Response Rate (ORR) (at least a PR or better) * Complete Response (CR) or better * Very Good Partial Response (VGPR) or better * Duration of Response (DoR)

Time frame
after each cycle (each cycle is 28 days) induction ( app. at month 1,2,...,6), after High Dose therapy (app. month 10), after each cycle (each cycle is 28 days) of maintenance (app. at month 11,12, ...28), during FU every 3 months (app. up to 3-4 years)
3

Progression Free Survival [efficacy]

Time frame
From randomization to the date of disease progression to death (app. up to 3-4 years)
4

Serum concentration of teclistamab, talquetamab and daratumumab [pharmacokinetics]

Time frame
through study completion, up to 28 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Heidelberg Medical Center

Lead sponsor

Janssen Research & Development, LLC

Collaborator

Deutsche Studiengruppe Multiples Myelom (DSMM)

Collaborator

Source ClinicalTrials.gov
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