Last updated on June 2020

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

Brief description of study

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.

Detailed Study Description


I. To compare overall survival in patients with high-risk smoldering multiple myeloma randomized to daratumumab-lenalidomide (revlimid)-dexamethasone or revlimid-dexamethasone.


I. To compare progression-free survival and response rates between arms. II. To evaluate safety and compare toxicity rates between arms. III. To monitor incidence of infusion-related reactions over the first cycle of daratumumab.

IV. To evaluate stem cell mobilization failure and early stem cell mobilization feasibility.


I. To measure treatment exposure and adherence. II. To estimate treatment duration and time to progression.


I. To compare change in health-related quality of life (Functional Assessment of Cancer Therapy [FACT]- General [G]]) from baseline to end of study therapy between arms.

II. To compare change in FACT-G scores from treatment end to 6-months post-treatment end between arms.

III. To describe changes in FACT-G scores over study therapy and shortly after treatment discontinuation and evaluate correlation with survival.

IV. To evaluate attributes of select patient reported treatment-emergent symptomatic adverse events (Patient Reported Outcomes [PRO]-Common Terminology Criteria for Adverse Events [CTCAE]) longitudinally.

V. To derive an overall PRO-CTCAE score at each assessment time point. VI. To measure the likelihood of medication adherence (ASK-12) at 6 month intervals throughout treatment.

VII. To assess the association of overall PRO-CTCAE score with FACT-G score. VIII. To compare select PRO-CTCAE items and related provider-reported CTCAEs. IX. To evaluate association between treatment adherence and Adherence Starts with Knowledge 12 (ASK-12) score.

X. To assess correlation of treatment adherence and ASK-12 score with FACT-G score.

XI. To tabulate PRO compliance and completion rates.


I. To compare minimal residual disease negative rate after 12 cycles of study therapy between arms.

II. To compare minimal residual disease (MRD) positive to negative conversion rates from 12 cycles to end of treatment between arms.

III. To examine patterns of change in minimal residual disease levels during study therapy.

IV. To evaluate agreement and discordance between methods determining disease-free status.

V. To assess the prognostic value of minimal residual disease status at 12 cycles for overall and progression-free survival.


I. To evaluate the association of baseline fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) imaging with progression-free survival.

II. To assess the ability of baseline FDG-PET/CT to predict minimal residual disease status after 12 cycles of study therapy and at the end of study therapy.

III. To describe the results of subsequent FDG-PET/CT imaging studies in the subset of patients with baseline abnormal FDG-PET/CT, and to associate these results with progression-free survival (PFS).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive daratumumab intravenously (IV) on days 1, 8, 15, and 22 of courses 1-2, days 1 and 15 of courses 3-6, and day 1 of courses 7-24. Patients also receive lenalidomide orally (PO) daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22 in courses 1-12. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22 of courses 1-12. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

After completion of study, patients will be followed up every 3, 6 or 12 months for up to 15 years from study entry.

Clinical Study Identifier: NCT03937635

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Alegent Health Mercy Hospital

Council Bluffs, IA United States
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Creighton University Medical Center

Omaha, NE United States
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University of Nebraska Medical Center

Omaha, NE United States
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Recruitment Status: Open

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