OncoMatch/Clinical Trials/NCT03937635
Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering Myeloma
Is NCT03937635 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Daratumumab and Dexamethasone for smoldering plasma cell myeloma.
Treatment: Daratumumab · Dexamethasone · Lenalidomide — This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients with smoldering myeloma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Biomarker criteria
Allowed: IGH t(4;14)
Presence of t(4;14) or del 17p, del 13q or 1q gain by conventional cytogenetics or fluorescence in situ hybridization (FISH) studies.
Allowed: TP53 deletion
Presence of t(4;14) or del 17p, del 13q or 1q gain by conventional cytogenetics or fluorescence in situ hybridization (FISH) studies.
Allowed: RB1 deletion
Presence of t(4;14) or del 17p, del 13q or 1q gain by conventional cytogenetics or fluorescence in situ hybridization (FISH) studies.
Allowed: CKS1B gain
Presence of t(4;14) or del 17p, del 13q or 1q gain by conventional cytogenetics or fluorescence in situ hybridization (FISH) studies.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy
Patients must not have any prior or concurrent systemic or radiation therapy for the treatment of myeloma.
Cannot have received: radiation therapy
Patients must not have any prior or concurrent systemic or radiation therapy for the treatment of myeloma.
Cannot have received: glucocorticosteroid therapy
Exception: Prior systemic glucocorticosteroid use for the treatment of non-malignant disorders is permitted; concurrent use after registration on the study should be restricted to the equivalent of prednisone 10 mg per day. Prior or concurrent topical or localized glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted.
Prior or glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted.
Lab requirements
Blood counts
Hemoglobin ≥ 11 g/dL; Platelet count ≥ 100,000 cells/mm^3; Absolute neutrophil count ≥ 1500 cells/mm^3 (within 28 days prior to randomization)
Kidney function
Calculated creatinine clearance ≥ 30 mL/min (within 28 days prior to randomization)
Liver function
Bilirubin ≤ 1.5 mg/dL; ALT and AST ≤ 2.5 x ULN (within 28 days prior to randomization)
Hemoglobin ≥ 11 g/dL (within 28 days prior to randomization). Platelet count ≥ 100,000 cells/mm^3 (within 28 days prior to randomization). Absolute neutrophil count ≥ 1500 cells/mm^3 (within 28 days prior to randomization). Calculated creatinine clearance ≥ 30 mL/min (within 28 days prior to randomization). Bilirubin ≤ 1.5 mg/dL (within 28 days prior to randomization). ALT and AST ≤ 2.5 x ULN (within 28 days prior to randomization).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
- Anchorage Associates in Radiation Medicine · Anchorage, Alaska
- Anchorage Radiation Therapy Center · Anchorage, Alaska
- Alaska Breast Care and Surgery LLC · Anchorage, Alaska
- Alaska Oncology and Hematology LLC · Anchorage, Alaska
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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