Massachusetts General Hospital
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.
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…
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…
Elranatamab is a bispecific IgG2 kappa monoclonal antibody.
Daratumumab is an immunoglobulin G1 kappa human monoclonal antibody against CD38 antigen.
Lenalidomide is a thalidomide analogue and an immunomodulatory agent with antiangiogenic properties.
Bortezomib for injection is a small molecule proteosome inhibitor.
Dexamethasone is a synthetic adrenocortical steroid.
Arctuva estimate
Verify or correct the compensation shown for this listing.