Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering Myeloma

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

Trial Details

NCT ID

NCT03937635

Phase

PHASE3

Sponsor

ECOG-ACRIN Cancer Research Group

Status

RECRUITING

Cancer Type

Multiple Myeloma

Interventions

Daratumumab
Dexamethasone
Lenalidomide
Quality-of-Life Assessment
Questionnaire Administration

Locations (sample)

Birmingham, Alabama, United States|33.52066,-86.80249
Anchorage, Alaska, United States|61.21806,-149.90028
Anchorage, Alaska, United States|61.21806,-149.90028
Anchorage, Alaska, United States|61.21806,-149.90028
Anchorage, Alaska, United States|61.21806,-149.90028

Key Eligibility Criteria

Patients must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 12 months. High-risk is defined by the pre…
Abnormal serum free light chain ratio of involved to uninvolved \>20, but less than 100 if the involved FLC is \>= 10 mg/dL by serum free light cha…
Serum M-protein level \>= 2 gm/dL
Presence of t(4;14) or del 17p, del 13q or 1q gain by conventional cytogenetics or fluorescence in situ hybridization (FISH) studies.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Multiple Myeloma Trials on Trialify →