A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and/or Refractory Multiple Myeloma

ConditionMultiple Myeloma

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorCelgene

About this trial

The purpose of this study is to evaluate the preliminary safety and determine the RP2D of mezigdomide in combination with elranatamab in participants with relapsed and refractory multiple myeloma (RRMM).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 with history of relapsed and refractory multiple myeloma (RRMM) treated with 2 to 4 prior lines of anti-myeloma therapy (Phase 1) or 1 to 3 prior lines of anti-myeloma therapy (Phase 2).

Measurable MM by local laboratory.

Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.

Adherence to contraception requirements.

Disqualifiers

Prior treatment with mezigdomide.

Prior treatment with T cell engaging or T cell engager (TCE).

Prior treatment with B cell-maturation antigen (BCMA)-targeting therapy, with the exception of participants who have received autologous BCMA-targeted CART-cell therapy> 6 months from the start of study therapy

Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Design model

Sequential

Treatments tested in this trial

Elranatamab
Drug
Specified dose on specified days
Mezigdomide
Drug
Specified dose on specified days
Dexamethasone
Drug
Specified dose on specified days

Treatment groups

62 Participants

are divided into 2 treatment groups

Group A: Phase 1Experimental treatment 3 interventions

Group B: Phase 2Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

Number of participants with Adverse Events (AEs)

Time frame

From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer

Number of participants with Serious AEs

Time frame

From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer

Number of participants with AEs meeting protocol-defined DLT criteria

Time frame

From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer

Number of participants with AEs leading to discontinuation

Time frame

From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer

Secondary outcomes

International Myeloma Working Group (IMWG) Uniform Response Criteria: Overall Response Rate (ORR)

Time frame

From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)

IMWG Uniform Response Criteria: Complete Response Rate (CRR)

Time frame

From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)

IMWG Uniform Response Criteria: Very Good Partial Response Rate (VGPRR)

Time frame

From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)

IMWG Uniform Response Criteria: Time to Response (TTR)

Time frame

From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)