What is daratumumab studying for high-risk smoldering myeloma?

Daratumumab is being studied to see if adding it to lenalidomide and dexamethasone improves treatment outcomes for patients with high-risk smoldering myeloma. Researchers want to find out if this combination helps patients live longer and delays disease progression. The trial is sponsored by the ECOG-ACRIN Cancer Research Group.

Who may be eligible for this smoldering myeloma clinical trial?

Adults aged 18 or older diagnosed with high-risk smoldering multiple myeloma within the past year may be eligible. The trial is open to all genders and requires no prior treatment for myeloma. Other health conditions and lab results also affect eligibility. Please review eligibility criteria for more details.

Is there any cost to participate in this smoldering myeloma clinical trial?

Study-related care, including study drugs and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID03937635

Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma DETER-SMM

Led by ECOG-ACRIN Cancer Research Group · Updated on 2026-05-15

288

Participants Needed

747

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating treatments for patients with high-risk smoldering multiple myeloma, a condition where abnormal plasma cells grow in the bone marrow but without symptoms. This phase III trial evaluates how well lenalidomide and dexamethasone work together, with or without the addition of daratumumab, an immunotherapy drug. The study aims to compare overall survival, progression-free survival, response rates, and quality of life between these two treatment approaches. Participants are randomly assigned to one of two treatment groups. One group receives daratumumab intravenously on a set schedule alongside oral lenalidomide daily and dexamethasone on specific days within repeated 28-day cycles, up to 24 cycles. The other group receives lenalidomide and dexamethasone on a similar schedule without daratumumab. Treatment continues until disease progression or unacceptable side effects occur. After treatment, patients are followed up for up to 15 years to monitor long-term outcomes. Throughout the study, participants undergo evaluations including blood and urine tests, bone marrow biopsies, and imaging scans such as FDG-PETCT. Researchers assess treatment response, minimal residual disease status, safety, and quality of life using questionnaires. They also monitor treatment adherence and side effects, including infusion reactions. The main outcomes measured are overall survival and changes in quality of life. Safety and various laboratory and imaging markers are regularly reviewed to understand treatment effects and disease progression.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Diagnosed with asymptomatic high-risk smoldering multiple myeloma within the past 12 months, defined by at least two high-risk factors
Bone marrow biopsy within 42 days prior to randomization showing 10-59% clonal plasma cells
Serum protein electrophoresis (SPEP) ≥ 1 g/dL and urine protein electrophoresis (UPEP) ≥ 200 mg in 24 hours within 28 days prior to randomization
No lytic bone lesions, plasmacytoma, or unexplained hypercalcemia
Hemoglobin ≥ 11 g/dL, platelet count ≥ 100,000/mm³, absolute neutrophil count ≥ 1500/mm³
Creatinine clearance ≥ 30 mL/min; bilirubin ≤ 1.5 mg/dL; liver enzymes ≤ 2.5 times upper limit of normal
No prior systemic or radiation therapy for myeloma
ECOG performance status 0 to 2
No grade 2 or higher peripheral neuropathy
No active uncontrolled infection or seizure disorder in past 6 months
Agreement to Risk Evaluation and Mitigation Strategy (REMS) program and birth control requirements for females and males
HIV+ patients with undetectable viral load within 6 months allowed
No history of allergic reactions to study drugs
No severe COPD or recent moderate/severe asthma

You will not qualify if you...

Presence of lytic bone lesions, plasmacytoma, or unexplained hypercalcemia
Prior systemic or radiation therapy for multiple myeloma
More than one focal marrow lesion on MRI of pelvis or spine
Active uncontrolled seizure disorder or seizure in past 6 months
Uncontrolled hypertension, heart failure class III or IV, unstable angina, or cardiac arrhythmia
Uncontrolled psychiatric illness or social situation limiting compliance
History of Stevens Johnson syndrome
Grade 2 or higher peripheral neuropathy
Active uncontrolled infection
Contraindications to deep vein thrombosis prophylaxis or aspirin
History of allergic reactions to daratumumab, lenalidomide, or dexamethasone
Known severe COPD or moderate/severe persistent asthma within 2 years prior to randomization

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