This research is testing whether the investigational drug isatuximab is safe and effective when used in combination with standard agents for the treatment of newly diagnosed multiple myeloma.
This is a multi-center, single-arm, open-label, Phase 2 study in patients with newly diagnosed multiple myeloma (NDMM) eligible for high dose therapy (HDT) and autologous stem cell transplant (ASCT). In this research study, investigators are evaluating whether isatuximab is safe and effective in participants with newly diagnosed multiple myeloma when given in combination with lenalidomide, bortezomib, and dexamethsone. * This research study involves administration of a four-drug chemotherapy regimen that combines the Investigational drug isatuximab with a standard chemotherapy regimen comprised of lenalidomide, bortezomib, and dexamethasone. * This 4-drug regimen is not considered standard of the treatment of newly diagnosed multiple myeloma. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug or combination of drugs to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has approved lenalidomide, bortezomib, and dexamethasone as treatment options for this disease but the combination of these agents with isatuximab hasn't been approved.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Via IV at predetermined dosage and predetermined days during each cycle
Oral, predetermined dosage and predetermined days during each cycle
SQ Oral, predetermined dosage and predetermined days during each cycle
Dana Farber Cancer Institute
Boston, Massachusetts, United States
stringent Complete Response (sCR)
proportion of patients who have achieved sCR, according to IMWG criteria, by the end of two cycles of induction treatment. Response will be evaluated using a Simon optimal two-stage design.
Time frame: 84 days
Time to Progression
Progression-free probabilities over time will be estimated using the Kaplan-Meier method (Kaplan, 1958), presenting an estimate of median time to progression (TTP) with 95% confidence intervals (CIs). Time to progression is defined as time from registration to progression, censored at date last known to be progression-free for those who have not progressed and censored at time of death for those who died.
Time frame: time from registration to progression, censored at date last known to be progression-free for those who have not progressed and censored at time of death up to 42 months
Progression Free Survival
\- Progression-free survival (PFS) will be analyzed similarly to time to progression: Progression-free probabilities over time will be estimated using the Kaplan-Meier method (Kaplan, 1958), presenting an estimate of median Time to progression (TTP) with 95% confidence intervals (CIs Time from registration to disease progression or death from any cause, censored at date last known to be progression-free for those who have not progressed or died
Time frame: time from registration to disease progression or death from any cause, censored at date last known to be progression-free for those who have not progressed or died up to 42 months
Duration of Response
Duration of Response will be analyzed similarly to time to progression: Progression-free probabilities over time will be estimated using the Kaplan-Meier method (Kaplan, 1958), presenting an estimate of median time to progression (TTP) with 95% confidence intervals (CIs Time from first response after treatment to the date of disease progression or death from any cause, or date last known progression-free and alive for those who have not progressed or died.
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IV or Oral predetermined dosage and predetermined days during each cycle
Time frame: Time from first response after treatment to the date of disease progression or death from any cause, or date last known progression-free and alive for those who have not progressed or died up to 42 months
Overall Survival
Overall Survival will be analyzed similarly to time to progression: Progression-free probabilities over time will be estimated using the Kaplan-Meier method (Kaplan, 1958), presenting an estimate of median time to progression (TTP) with 95% confidence intervals (CIs Overall survival: time from registration to death from any cause or date last known alive for those who have not died
Time frame: Overall survival: time from registration to death from any cause or date last known alive for those who have not died up to 42 months
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v 5.0
Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) v5.0
Time frame: Induction to up to 3.5 years