MMulti-Immune HR; Multi-Target Immunotherapy for High-Risk Multiple Myeloma

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
University of Arkansas
Study ID
NCT07029776
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Multiple Myeloma (MM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • teclistamab+daratumumab followed by talquetamab+daratumumab followed by duration treatment with daratumumab and lenalidomide extended/maintenance — DRUG
    teclistamab+daratumumab followed by talquetamab+daratumumab each for 4 cycles followed by 2-year fixed duration treatment with daratumumab and lenalidomide extended/maintenance therapy for a maximum of 24 cycles, or until myeloma progression.
  • melphalan (MEL)-based hematopietic stem cell transplantation (HSCT) followed by drug therapy — PROCEDURE
    Subjects who are MRD-positive (a threshold of 10\^5) will receive a single melphalan (MEL)-based hematopietic stem cell transplantation (HSCT) followed by teclistamab+daratumumab followed by talquetamab+daratumumab each for 4 cycles followed by a 2-year fixed duration treatment with daratumumab and lenalidomide extended/maintenance therapy for a maximum of 24 cycles, or until myeloma progression.

Study Details

The purpose of this research is to learn whether using teclistamab and talquetamab at different time points will improve survival in participants with high-risk Multiple Myeloma (MM). The treatment on this study will consist of Induction chemotherapy and stem cell collection, Immunotherapy 1 chemotherapy and Immunotherapy 2 chemotherapy. For participants whose testing show they are Minimal Residual Disease (MRD) positive (still have myeloma cells present in the bone marrow testing), a Melphalan-based stem cell transplant will be performed. For participants whose testing show they are MRD negative, the stem cell transplant will not be performed. All participants will go on to receive Immunotherapy 3 chemotherapy, Immunotherapy 4 chemotherapy, and Maintenance therapy.

Key Dates

Start date
Jul 1, 2026
Status verified
Mar 2026
Primary completion
Apr 1, 2030
Completion
Apr 1, 2032

Study Design

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

Arms

  • Experimental: MRD-negative
    Subjects who are MRD-negative (a threshold of 10\^5) will be given teclistamab+daratumumab followed by talquetamab+daratumumab each for 4 cycles followed by 2-year fixed duration treatment with daratumumab and lenalidomide extended/maintenance therapy for a maximum of 24 cycles, or until myeloma progression.
  • Experimental: MRD-positive
    Subjects who are MRD-positive (a threshold of 10\^5) will receive a single melphalan (MEL)-based hematopietic stem cell transplantation (HSCT) followed by teclistamab+daratumumab followed by talquetamab+daratumumab each for 4 cycles followed by a 2-year fixed duration treatment with daratumumab and lenalidomide extended/maintenance therapy for a maximum of 24 cycles, or until myeloma progression. MRD status with classification threshold of 10\^5 will be assessed by standardized flow cytometry.

Primary Outcome Measure

Complete Response Rate (CRR) in subjects with high-risk multiple myeloma (HRMM) treated with the sequential use of Bispecific Antibodies. [ Time Frame: Up to 4 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72120-

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University of Arkansas for Medical Sciences· Little Rock, AR

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