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A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant

ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer

About this trial

Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in people with newly diagnosed multiple myeloma.

There are 2 parts to this study. Part 1 will characterize the safety and tolerability of elranatamab in combination with daratumumab and lenalidomide or in combination with lenalidomide and will identify the optimal dose(s) of the combination regimen. Part 2 of the study will evaluate the rate of minimal residual disease (MRD) negative CR and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of multiple myeloma (MM) as defined by IMWG criteria (Rajkumar et al., 2014)

Serum M-protein ≥0.5 g/dL (Part 1) and ≥1 g/dL (Part 2);

Urinary M-protein excretion ≥200 mg/24 hours;

Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).

Disqualifiers

Smoldering Multiple Myeloma.

Monoclonal gammopathy of undetermined significance.

Waldenströms Macroglobulinemia

Plasma cell leukemia.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Elranatamab

    Drug

    Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.

  • Daratumumab

    Drug

    Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.

  • Lenalidomide

    Drug

    Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.

  • Dexamethasone

    Drug

    Randomized

  • Bortezomib

    Drug

    Randomized

Treatment groups

1,116 Participants
are divided into 5 treatment groups
Group A: Part 1, Dose Level 1: Elranatamab + Daratumumab + LenalidomideExperimental treatment 3 interventions
Group B: Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + LenalidomideExperimental treatment 3 interventions
Group C: Part 2 Randomized Arm A: Elranatamab + Daratumumab + LenalidomideExperimental treatment 3 interventions
Group D: Part 2 Randomized Arm B: Daratumumab + Bortezomib + Lenalidomide + DexamethasoneActive comparator 4 interventions
Group E: Part 1: Elranatamab + LenalidomideExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part 1 Dose Limiting Toxicity

Time frame
From the first dose of elranatamab/first full dose in combination with EDR until 28 days (+/- visit window) from the first administration of elranatamab with daratumumab and lenalidomide
2

Part 2: Progression free survival per IMWG

Time frame
From randomization up to 97 months.
3

Part 2: Minimal Residual Disease negative CR rate

Time frame
At 12 months after randomization

Secondary outcomes

1

Overall Survival

Time frame
From date of randomization up to 97 months
2

Overall minimal residual disease negative CR rate

Time frame
From date of randomization up to 97 months
3

Sustained MRD negative CR rate (Part 2)

Time frame
From date of randomization up to 97 months
4

Duration of minimal residual disease negative CR (Part 2)

Time frame
From date of minimal residual disease negative CR status up to 97 months

Other outcomes

Sponsors and contacts

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

Pfizer

Lead sponsor

Source ClinicalTrials.gov
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