Health Trials

A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

ConditionRelapsed or Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCelgene

About this trial

The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants received 1 to 3 prior lines of antimyeloma therapy.

Participants achieved minimal response [MR] or better to at least 1 prior antimyeloma therapy.

Disqualifiers

For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.

Participant has had prior treatment with mezigdomide or pomalidomide.

Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Design model

Parallel

Treatments tested in this trial

  • mezigdomide

    Drug

    Specified dose on specified days

  • Pomalidomide

    Drug

    Specified dose on specified days

  • Bortezomib

    Drug

    Specified dose on specified days

  • Dexamethasone

    Drug

    Specified dose on specified days

Treatment groups

810 Participants
are divided into 2 treatment groups
Group A: MeziVd (mezigdomide, bortezomib and dexamethasone)Experimental treatment 3 interventions
Group B: PVd (pomalidomide, bortezomib and dexamethasone)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Progression-free Survival (PFS)

Time frame
From date of randomization to date of disease progression or death due to any cause (Up to approximately 5 years)

Secondary outcomes

1

Recommended mezigdomide dose

Stage 1 only

Time frame
Up to 12 Months
2

Plasma concentrations of mezigdomide

Stage 1 only

Time frame
Up to 134 Days
3

Overall Survival (OS)

Time frame
From date of randomization to date of death due to any cause (Up to approximately 5 years)
4

Overall Response (OR)

OR is defined as the number of participants who achieve best response of partial response (PR) or better according to the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma

Time frame
Up to approximately 5 years

Other outcomes

Sponsors and contacts

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

Celgene

Lead sponsor

Source ClinicalTrials.gov
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