Immuno-Oncology Therapy for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen byMadhav V. Dhodapkar, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Multiple Myeloma Research Consortium

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This a Phase I/II randomized trial for patients with relapsed refractory Multiple Myeloma who have relapsed after treatment with prior therapies. The protocol is designed to evaluate two agents, Anti-LAG-3 and Anti-TIGIT, in order to understand their immunologic effects and safety both as single agents and in combination with pomalidomide and dexamethasone. In these arms, patients will be treated with either Anti-LAG-3 or Anti-TIGIT respectively for one cycle as single agent followed by the addition of pomalidomide and dexamethasone in combination for subsequent cycles. A third arm allows patients to be treated with the FDA approved combination of elotuzumab plus pomalidomide and dexamethsone as a control. This arm will thus allow a concurrent standard of care comparator for the experimental arms.

Eligibility Criteria

Adults with relapsed refractory Multiple Myeloma who've had at least three prior treatments, including IMiDs, proteasome inhibitors, and anti-CD38 monoclonal antibodies. Participants must have normal or stable thyroid function, acceptable blood counts and organ function, no history of certain autoimmune diseases or CNS involvement, not be pregnant or breastfeeding, and agree to contraception use.

Inclusion Criteria

I am willing to go back to the hospital where I enrolled for my check-ups.

Willing and able to provide informed consent

Criterion: Your recent blood tests show certain levels within a specific range. For example, your white blood cell count needs to be above a certain number, and your hemoglobin and platelet levels need to be within a certain range. Your liver and kidney function also need to be within a specific range.

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Exclusion Criteria

I haven't taken any cancer treatments or investigational drugs within the specified time frames before starting this therapy.

I cannot tolerate blood clot prevention treatments.

You have had a serious skin reaction or severe allergic reaction to similar medications in the past.

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Treatment Details

Interventions

Anti-LAG-3 (Monoclonal Antibodies)
Anti-TIGIT (Monoclonal Antibodies)
Dexamethasone (Corticosteroid)
Elotuzumab (Monoclonal Antibodies)
Pomalidomide (Immunomodulator)

Trial OverviewThe trial is testing Anti-LAG-3 and Anti-TIGIT immunotherapy drugs alone and in combination with pomalidomide plus dexamethasone against the standard FDA-approved combo of elotuzumab with pomalidomide and dexamethasone. It aims to assess their safety profile and effect on the immune system in multiple myeloma treatment.

Participant Groups

5Treatment groups

Experimental Treatment

Active Control

Group I: Arm C - Anti-TIGIT Single AgentExperimental Treatment1 Intervention

Patients receive Anti-TIGIT as a single agent for 1 Cycle in Phase 1 portion.

Group II: Arm B:Combination Anti LAG-3 +Pomalidomide+DexamethasoneExperimental Treatment1 Intervention

Cycle 2 and beyond Patients receive Anti-LAG-3 in combination with pomalidomide and dexamethasone.

Group III: Arm B - Anti LAG-3 Single AgentExperimental Treatment1 Intervention

Patients receive Anti-LAG-3 as a single agent for 1 Cycle in Phase 1 portion.

Group IV: ARM C: Anti-TIGIT +Pomalidomide+DexamethasoneExperimental Treatment1 Intervention

Cycle 2 and beyond Patients receive Anti-TIGIT in combination with pomalidomide and dexamethasone.