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Mezigdomide and Talquetamab in Relapsed and Refractory Multiple Myeloma

ConditionRelapsed Refractory Multiple Myeloma (RRMM)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

This is a phase 1 study to find the recommended dose and schedule of mezigdomide and talquetamab in relapsed and refractory multiple myeloma (RRMM), and to test the effects of the drugs on cancer. Cohort A will receive talquetamab + dexamethasone, then mezigdomide + talquetamab,+ dexamethasone. After Cohort A, Cohort B will evaluate mezigdomide + dexamethasone followed by step-up dosing of talquetamab (mezigdomide + talquetamab,+ dexamethasone).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to their future medical care.

Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (see Appendix).

Age ≥ 18 years

Serum monoclonal protein ≥ 0.5 g/dL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval

Disqualifiers

Participants who have had myeloma therapy or investigational drug within 2 weeks prior to start of treatment or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.

Participants who are receiving any investigational agents.

Prior therapy with mezigdomide or iberdomide.

Prior therapy with anti-GPRC5D therapy (e.g. talquetamab).

Trial design

Design model

Sequential

Treatments tested in this trial

  • Talquetamab

    Drug

    Talquetamab is injected under the skin (subcutaneously injected) by trained medical staff. During first cycle of talquetamab, the dose of talquetamab will increase until the goal dose (treatment dose) is reached (pre-determined dose escalation).

  • Mezigdomide

    Drug

    Administered orally once per day (days 1-21 of applicable 28-day cycles; Days 1-7 of the 7-day Cohort B pre-phase cycle).

  • Dexamethasone

    Drug

    Administered orally once per day, at the schedule outlined in the Arm Descriptions.

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Cohort AExperimental treatment 3 interventions
Group B: Cohort BExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Recommended Dose

To determine the recommended dose and schedule of mezigdomide and talquetamab in triple class exposed, relapsed and refractory multiple myeloma (RRMM), the dose level where 2 of 6 participants experience a DLT is considered the maximum tolerated dose. The dose level below this will be considered a recommended phase 2 dose. Or if dose level 2 is reached (mezigdomide 1 mg po for 21 out of 28 days) and there are ≤1 DLTs out of 6 participants, then dose level 2 will be considered the recommended phase 2 dose. Data from the secondary outcomes (frequency of adverse events, serious adverse events, and dose-limiting toxicities) will be used for this outcome.

Time frame
Day 1 of treatment through 30 days post last-dose (treatment is until disease progression or withdrawal; estimated to be 1 year from Day 1 of treatment)

Secondary outcomes

1

Frequency of adverse events

Assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, the frequency of AEs will be tabulated by cohort and dose.

Time frame
Day 1 of treatment through 30 days post last-dose (treatment is until disease progression or withdrawal; estimated to be 1 year from Day 1 of treatment)
2

Frequency of serious adverse events

Assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, the frequency of serious AEs will be tabulated by cohort and dose.

Time frame
Day 1 of treatment through 30 days post last-dose (treatment is until disease progression or withdrawal; estimated to be 1 year from Day 1 of treatment)
3

Frequency of dose-limiting toxicities (DLT)

Unacceptable toxicity will be defined as grade 3-4 CRS, grade 3-4 ICANS, and grade 4, treatment-related, non-hematologic adverse events. Assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 when applicable. The frequency and type of DLTs will be tabulated by cohort and dose.

Time frame
Day 1 of treatment through 30 days post last-dose (treatment is until disease progression or withdrawal; estimated to be 1 year from Day 1 of treatment)
4

Overall response rate (ORR)

Response rate will be according to IMWG criteria. Overall response rate is rate of patients achieving partial response or better.

Time frame
Day 1 of treatment through 2 years post last-dose (estimated total time to be 3 years; treatment is until disease progression or withdrawal)

Other outcomes

Sponsors and contacts

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

Massachusetts General Hospital

Lead sponsor

Celgene Corporation

Collaborator

Janssen Research and Development LLC

Collaborator

Source ClinicalTrials.gov
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