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Mezigdomide and Elranatamab for Relapsed and/or Refractory Multiple Myeloma

ConditionRelapsed Refractory Multiple Myeloma (RRMM)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorYOUNGIL KOH

About this trial

The goal of this clinical trial is to find out how well a combination of two medicines (mezigdomide and elranatamab) works in treating patients with refractory/relapsed multiple myeloma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject is ≥ 19 years of age at the time of signing the informed consent form (ICF).

Subject is willing and able to adhere to the study visit schedule and other protocol requirements.

Subject must have documented disease progression during or after their last antimyeloma regimen.

True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., calendar, ovulation, post-ovulation methods) and withdrawal are not acceptable methods of contraception].

Disqualifiers

1 Subject who has had prior treatment with mezigdomide. 2 Patients with gastrointestinal disease or surgery (eg, gastric bypass surgery) that may significantly alter the absorption of mezigdomide and/or other oral study intervention.

Trial design

Design model

Single group

Treatments tested in this trial

  • Elranatamab

    Drug

    Elranatamab: Participants will receive SC administration of elranatamab QW or Q2W. The initial doses of elranatamab will be 12mg (C0D1), 32mg (C0D4), and 76mg (C0D8) and will serve as the 2 step-up priming regimen (Cycle 0). Then, 76mg weekly C1-C6 \> then 76mg bi-weekly from C7 for those achieving PR or better \> then 76mg q4weeks from C12 for those achieving CR or better response. If the participant subsequently begins to have an increase of disease burden not yet qualifying as PD according to IMWG criteria, dose intervals will return to weekly dosing. premedication for Elranatamab: Acetaminophen 650mg (or paracetamol 500mg), Diphenhydramine 25mg (or equivalent), Dexamethasone 20mg (or equivalent). In case of mezigdomide discontinuation due to reasons other than disease progression, elranatamab continuation +/- dexamethasone will be allowed until loss of response. The administration of elranatamab +/- dexamethasone will continue per study protocol schedule.

  • Mezigdomide

    Drug

    The first day of study treatment dosing with mezigdomide is considered Day 1 of a cycle. (per recommended phase 2 dose, daily \[qd\], D1-21, q 4weeks). Capsules of mezigdomide will be taken by mouth with or without food. In case of elranatamab discontinuation due to reasons other than disease progression, mezigdomide continuation +/- dexamethasone will be allowed until loss of response. The administration of mezigdomide will continue per study protocol.

  • Dexamethasone

    Drug

    Administered at the dose of 20 mg/day from C1-3, then 10mg/day from C4-6 as a premedication for elranatamab. (for those \>=75 yrs, with uncontrolled diabetes mellitus, history of intolerance: 10mg/day -\> 5mg/day)

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: Treatment armExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Overall response rate (ORR)

Percentage of subjects who achieve best response of partial response (PR) or better according to the IMWG Uniform Response Criteria for Multiple Myeloma

Time frame
From C1D1 to confirmed PD, lost to follow-up, or death (whichever occurs first), assessed up to 24 months

Secondary outcomes

1

Progression-free survival (PFS)

Time from randomization to first documentation of progressive disease (PD) according to the IMWG Uniform Response Criteria for Multiple Myeloma (Kumar, 2016) or death due to any cause, whichever occurs first.

Time frame
From randomization to first documentation of progressive disease or death due to any cause, assessed up to 24 months.
2

Overall survival (OS)

Time frame
Time from randomization to time of death due to any cause, assessed up to 24 months.
3

Complete Response Rate (CR) or better

Percentage of subjects who achieve best response of complete response (CR) or better according to the IMWG Uniform Response Criteria for Multiple Myeloma (Kumar, 2016).

Time frame
From C1D1 to confirmed PD, lost to follow-up, or death (whichever occurs first), assessed up to 24 months
4

Very Good Partial Response Rate (VGPR) or better

Percentage of subjects who achieve best response of very good partial response (VGPR) or better according to the IMWG Uniform Response Criteria for Multiple Myeloma (Kumar, 2016).

Time frame
From C1D1 to confirmed PD, lost to follow-up, or death (whichever occurs first), assessed up to 24 months

Other outcomes

1

Biomarkers

Correlation of baseline RNA/protein expression, gene expression, cytogenetics, copy number abnormalities and/or mutations in tumor cells to treatment response. Correlation of changes in RNA/protein expression, gene expression or genomic abnormalities in tumor cells to disease progression

Time frame
From C1D1 to End of trial, assessed up to 24 months.

Sponsors and contacts

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

YOUNGIL KOH

Lead sponsor

Seoul National University Hospital

Sponsor institution

Source ClinicalTrials.gov
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