Summary
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.
Description
PRIMARY OBJECTIVES:
I. To compare overall survival in patients with high-risk smoldering multiple myeloma randomized to daratumumab-lenalidomide (revlimid)-dexamethasone or revlimid-dexamethasone.
SECONDARY OBJECTIVES:
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.
EXPLORATORY OBJECTIVES:
I. To measure treatment exposure and adherence. II. To estimate treatment duration and time to progression.
PATIENT-REPORTED OUTCOMES OBJECTIVES:
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.
Principal Investigator
Study Coordinator
Faculty Contact
Lisa Luikart - lisa.luikart@vandaliahealth.org