ELDORADO: a Randomized Phase II Trial of Elranatamab or Daratumumab in Combination With Lenalidomide, Bortezomib, and Dexamethasone (RVd Lite) in Newly Diagnosed, Transplant Ineligible/Deferred Multiple Myeloma
Massachusetts General Hospital
Summary
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.
Description
The ELDORADO trial is a phase 2, randomized, open label, multicenter study that will enroll approximately 160 patients (10 patient safety run and 150 patients for randomization) to compare the efficacy and safety of the combination of elranatamab, lenalidomide, bortezomib, dexamethasone versus the standard combination of daratumumab and hyaluronidase, lenalidomide, bortezomib, dexamethasone in newly diagnosed, transplant ineligible/deferred multiple myeloma patients. Pfizer, Inc. is supporting this research by providing the study drug, elranatamab, and funding for research activities. Patients…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 a. CRAB criteria, one or more of the following: i. Hypercalcemia: serum calcium (\>1 mg/dL) higher than the upper limit of normal or \>11 mg/dL ii. Renal insufficiency: creatinine clearance \<40 mL/min (calculated per local practice) or serum creatinine \>2 mg/dL iii. Anemia: hemoglobin value \>2 g/dL below the lower limit of normal or hemoglobin \<10 g…
Interventions
- DrugElranatamab (PF-06863135)
Elranatamab is a bispecific IgG2 kappa monoclonal antibody.
- DrugDaratumumab and Hyaluronidase-fihj
Daratumumab is an immunoglobulin G1 kappa human monoclonal antibody against CD38 antigen.
- DrugLenalidomide
Lenalidomide is a thalidomide analogue and an immunomodulatory agent with antiangiogenic properties.
- DrugBortezomib for Injection
Bortezomib for injection is a small molecule proteosome inhibitor.
- DrugDexamethasone
Dexamethasone is a synthetic adrenocortical steroid.
Locations (3)
- Massachusetts General HospitalBoston, Massachusetts
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts