Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female subject aged ≥ 18 years.
Histologically confirmed myeloma and/or Plasma Cell Leukemia who are newly diagnosed and having completed ≤ 1 prior cycle of myeloma treatment.
For female subjects of childbearing potential: Negative pregnancy test or evidence of post-menopausal status or evidence of permanent surgical sterilization (bilateral oophorectomy or hysterectomy). The post-menopausal status will be defined as having been amenorrheic for 24 months without an alternative medical cause.
Subjects must be willing to follow contraception requirements listed in the protocol, agree to participate in the Lenalidomide REMS program, and have signed the Patient-Physician Agreement Form.
Disqualifiers
Receiving other investigational agents.
Any condition that would, in the Investigator's judgment, compromise the subject's ability to understand the subject information, give informed consent, and/or contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, [subjects may not receive the drug through a feeding tube], social/ psychological issues, etc.)
Known prior severe hypersensitivity (NCI CTCAE v5.0 Grade ≥ 3) to investigational product (IP) or any component in its formulations. This includes hypersensitivity or history of intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study intervention that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.
Subjects currently taking prohibited medications as described in the protocol.
Trial design
Design model
Single group
Treatments tested in this trial
Isatuximab
DrugSubcutaneous isatuximab will be administered weekly on a 28-day cycle during the first two cycles, and every two weeks of a 28-day cycle thereafter. Dexamethasone will be administered on the days of isatuximab administration and can be discontinued after two cycles of therapy, or continued at discretion of investigator. Lenalidomide, will be added after two cycles of therapy have been completed.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Combination TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
At the end of 9 cycles of treatment (each cycle is 28 days)Secondary outcomes
1
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).
Time frame
At the end of 4 cycles of treatment (each cycle is 28 days)2
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.
Time frame
At study completion. Participants will be enrolled in study for about 3 years.3
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.
Time frame
At study completion. Participants will be enrolled in study for about 3 years.4
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.
Time frame
At study completion. Participants will be enrolled in study for about 3 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Utah
Lead sponsor
Sanofi
Collaborator
Source ClinicalTrials.gov