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

Conditions

• Multiple Myeloma
• Newly Diagnosed Multiple Myeloma
• Newly Diagnosed Multiple Myeloma (NDMM)
• Transplant Ineligible

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Apr 15, 2026

Status verified

Nov 2025

Primary completion

Dec 1, 2030

Completion

Dec 1, 2035

Study Design

Enrollment

160 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Elranatamab with lenalidomide, bortezomib, and dexamethasone (elra-RVd lite)
  The first 10 patients will enroll in the elranatamab arm for a one 14-day safety run-in cycle. Elranatamab and dexamethasone will be administered at pre-determined doses on days 1, 4, and 8 of the cycle. After randomization occurs, patients in the elra-RVd lite arm will complete 24 cycles (each cycle is 28 days) of treatment. On day 1 of each cycle and day 15 of cycle 1, the pre-determined dose of elranatamab will be administered via subcutaneous injection. On days 1-21 of each cycle, patients will take the pre-determined dose of oral lenalidomide. One days 1, 8, and 15 of cycles 1-8, the pre-determined dose of bortezomib will be administered via subcutaneous injection. After completion of 24 treatment cycles, patients who have had two MRD negative tests, one year apart, may discontinue treatment and enter the observation phase of the trial. Patients who have not had two MRD negative tests one year apart, may continue elranatamab lenalidomide treatment for another 24 cycles.
• Experimental: Daratumumab with lenalidomide, bortezomib, and dexamethasone (dara-RVd lite)
  After randomization occurs, patients in the dara-RVd lite arm will complete 24 cycles (each cycle is 28 days) of treatment. On days 1, 8, 15, and 22 of cycles 1 and 2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7+, the pre-determined dose of daratumumab will be administered via subcutaneous injection. On days 1-21 of each cycle, patients will take the pre-determined dose of oral lenalidomide. One days 1, 8, and 15 of cycles 1-8, the pre-determined dose of bortezomib will be administered via subcutaneous injection. On days 1, 2, 8, 9, 15, 16 of cycles 3+, as well as days 22 and 23 of cycles 1 and 2, patients will take the pre-determined dose of oral dexamethasone.

Primary Outcome Measure

Proportion Patients who test Negative for Minimal Residual Disease (MRD) at 10^-5 after 4 Treatment Cycles [ Time Frame: Day 1 of Cycle 1 (each cycle is 28 days) to Day 28 of Cycle 4. ]

Central Contacts

• Andrew Yee, MD
  617-726-4000
  [email protected]

Locations (3)

Find similar trials in Boston, MA

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