Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma
NCT Number: NCT06517017
Acronym: UltraFrailMM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Multiple Myeloma|Plasma Cell Leukemia
Interventions: DRUG: Isatuximab
Sponsor: University of Utah
Collaborators: Sanofi
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-09
Locations: Huntsman Cancer Institute at the University of Utah, Salt Lake City, Utah, 84112, United States

Summary:
Historically, the frailest patients with multiple myeloma are under-represented in clinical trials, and have very high rates of treatment discontinuation, and early treatment mortality. The investigators hypothesize that a go-slow gentle approach to starting treatment in such patients, starting with just Isatuximab and dexamethasone with a gentle introduction to lenalidomide third cycle onwards, may improve treatment adherence and quality of life. The goal of this clinical trial is to learn if a go-slow approach to treating MM in ultra-frail patients may improve the ability to adhere to treatment and improve quality of life.

Primary Outcome Measures: Completion rate of 9 cycles of treatment, Assess the feasibility of approach incorporating the use of isatuximab and dexamethasone with the subsequent addition of lenalidomide from the third cycle onwards in ultra-frail patients with myeloma, At the end of 9 cycles of treatment (each cycle is 28 days)
Secondary Outcome Measures: Change in quality of life as per the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 domain, Assess if an approach incorporating the use of isatuximab and dexamethasone with the subsequent addition of a lenalidomide in ultra-frail patients with myeloma leads to an improvement in quality of life as measured by the EORTC score. The questionnaire has 10 subscales, each with a score range of 0 to 100 points. Higher scores on the functional scales and global quality of life indicate better functioning, while higher scores on the symptom scales indicate a higher symptom burden. The QLQ-C30 summary score is calculated by averaging the scores of the 13 scales and items, with a higher score indicating a better health-related quality of life (HRQoL)., At the end of 4 cycles of treatment (each cycle is 28 days)|Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, Assess the safety and tolerability of isatuximab, lenalidomide and dexamethasone in the study population., At study completion. Participants will be enrolled in study for about 3 years.|Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0), Assess the safety and tolerability of isatuximab, lenalidomide and dexamethasone in the study population., At study completion. Participants will be enrolled in study for about 3 years.|Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness, Assess the safety and tolerability of isatuximab, lenalidomide and dexamethasone in the study population., At study completion. Participants will be enrolled in study for about 3 years.|Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration, Assess the safety and tolerability of isatuximab, lenalidomide and dexamethasone in the study population., At study completion. Participants will be enrolled in study for about 3 years.|Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study treatment, Assess the safety and tolerability of isatuximab, lenalidomide and dexamethasone in the study population., At study completion. Participants will be enrolled in study for about 3 years.|Overall survival (OS), Assess overall survival in this study population, Time from registration until 3 years from start of therapy or death from any cause.