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ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible/Deferred Multiple Myeloma

ConditionsMultiple MyelomaNewly Diagnosed Multiple MyelomaTransplant IneligibleNewly Diagnosed Multiple Myeloma (NDMM)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

This research study is being done to compare the efficacy and safety of the combination of elranatamab, lenalidomide, bortezomib, dexamethasone versus the combination of daratumumab, lenalidomide, bortezomib, dexamethasone for patients with newly diagnosed, transplant ineligible/deferred multiple myeloma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must be at least 18 years of age

Newly diagnosed multiple myeloma, with monoclonal plasma cells in the bone marrow ≥10% or a biopsy proven plasmacytoma and either CRAB criteria or biomarker of malignancy

Serum monoclonal protein ≥0.5 g/dL. For IgA monoclonal protein, total IgA >500 mg/dL is allowable.

Urine monoclonal protein ≥200 mg/24 hours

Disqualifiers

Prior or current systemic therapy for any plasma cell disorder. An exception is emergency use of corticosteroids (equivalent to dexamethasone 40 mg daily for four days). After discussion with the principal investigator. one cycle of standard of care myeloma therapy (without anti-CD38 monoclonal antibody) is permissible to allow for stabilization of disease, during screening/prior to enrollment.

Pregnancy, currently breastfeeding, or planned breastfeeding.

Participant plans to father a child while enrolled in the study or within 100 days after last dose of study treatment.

Basal or squamous cell carcinoma of the skin

Trial design

Design model

Parallel

Treatments tested in this trial

  • Elranatamab (PF-06863135)

    Drug

    Elranatamab is a bispecific IgG2 kappa monoclonal antibody.

  • Daratumumab and Hyaluronidase-fihj

    Drug

    Daratumumab is an immunoglobulin G1 kappa human monoclonal antibody against CD38 antigen.

  • Lenalidomide

    Drug

    Lenalidomide is a thalidomide analogue and an immunomodulatory agent with antiangiogenic properties.

  • Bortezomib for Injection

    Drug

    Bortezomib for injection is a small molecule proteosome inhibitor.

  • Dexamethasone

    Drug

    Dexamethasone is a synthetic adrenocortical steroid.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Elranatamab with lenalidomide, bortezomib, and dexamethasone (elra-RVd lite)Experimental treatment 4 interventions
Group B: Daratumumab with lenalidomide, bortezomib, and dexamethasone (dara-RVd lite)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Proportion Patients who test Negative for Minimal Residual Disease (MRD) at 10^-5 after 4 Treatment Cycles

Evaluated at 1 x 10\^-5 using next generation sequencing (NGS) to detect clonal sequences. The proportions will be compared using the Cochran-Mantzel-Haenszel test, stratified by the randomization stratification factors. A one-sided significance level of 0.05 will be used. Patients without successful baseline minimal residual disease (MRD) testing will not be evaluated for MRD response. Proportion patients who test negative for MRD at 10\^-5 after 4 treatment cycles will be compared between the elran-RVd lite arm and the dara-RVd lite arm.

Time frame
Day 1 of Cycle 1 (each cycle is 28 days) to Day 28 of Cycle 4.

Secondary outcomes

1

Progression-Free Survival (PFS)

Progression-free survival (PFS) is the time from randomization to disease progression or death from any cause. PFS distributions will be calculated using the Kaplan-Meier method. PFS will be compared between the elran-RVd lite arm and the dara-RVd lite arm.

Time frame
Day 1 of Cycle 1 (each cycle is 28 days) to documentation of disease progression or death from any cause (up to 5 years). Patients who have not progressed or died are censored at the date last known progression-free.
2

Overall Survival (OS)

Overall survival (OS) is the time from start of treatment to death due to any cause. OS distributions will be calculated using the Kaplan-Meier method. OS will be compared between the elran-RVd lite arm and the dara-RVd lite arm.

Time frame
Day 1 of Cycle 1 (each cycle is 28 days) to documentation of death due to any cause or censored at the date last known alive, up to 5 years from study registration.
3

Overall Response Rate (ORR)

Overall response rate (ORR) is the proportion of patients achieving partial response or better, along with very good partial response and complete response per the International Myeloma Working Group Response Criteria (IMWG). All IMWG response categories will require one confirmation. ORR will be compared between the elran-RVd lite arm and the dara-RVd lite arm.

Time frame
Day of initiation of first response to the first documentation of disease progression or death, up to 5 years after registration. Patients who have not progressed or died are censored at the date last known progression-free.
4

Proportion Patients who test Negative for Minimal Residual Disease (MRD) at 10^-5 after 12 Treatment Cycles

Evaluated at 1 x 10\^-5 using next generation sequencing (NGS) to detect clonal sequences. The proportions will be compared using the Cochran-Mantzel-Haenszel test, stratified by the randomization stratification factors. A one-sided significance level of 0.05 will be used. Patients without successful baseline minimal residual disease (MRD) testing will not be evaluated for MRD response. Proportion patients who test negative for MRD at 10\^-5 after 12 treatment cycles will be compared between the elran-RVd lite arm and the dara-RVd lite arm.

Time frame
Day 1 of Cycle 1 (each cycle is 28 days) to Day 28 of Cycle 12.

Other outcomes

Sponsors and contacts

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

Massachusetts General Hospital

Lead sponsor

Pfizer

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: