Health Trials

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

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

Treatments tested in this trial

  • Teclistamab (Tec)
  • Daratumumab
  • Dexamethasone
  • Lenalidomide
  • Bortezomib
  • Talquetamab
  • JNJ-79635322

Treatment groups

160 Participants
are divided into 11 treatment groups

11

Treatment groups

See each treatment group below.

Sponsors and collaborators

University of Heidelberg Medical Center

Lead sponsor

Janssen Research & Development, LLC

Collaborator

Deutsche Studiengruppe Multiples Myelom (DSMM)

Collaborator

Source ClinicalTrials.gov