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The main study consists of 4 phases a) 28-day screening phase; b) an induction phase inclusive of two 42-day induction treatment cycles: Isatuximab (IV), Bortezomib (SQ). Lenalidomide (PO), Dexamethasone; c) Followed by stem cell mobilization (at the discretion of the Principal Investigator \[PI\]);d) Participants will proceed with either autologous stem cell transplant or two additional induction cycles.

- Induction will be followed by a maintenance phase that continues until disease progression.

Via IV at predetermined dosage and predetermined days during each cycle

Isatuximab

Oral, predetermined dosage and predetermined days during each cycle

SQ Oral, predetermined dosage and predetermined days during each cycle

Bortezomib Injection

IV or Oral predetermined dosage and predetermined days during each cycle

Jacob C Laubach, MD

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.

Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in NDMM

Phase 2, Multi-Center, Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of the Combination Regimen Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

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.

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.

- 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

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.

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

Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) v5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in NDMM	NCT04653246	Multiple Myelom... Newly Diagnosed... Autologous Stem...	Isatuximab Lenalidomide Bortezomib Inje... Dexamethasone	75 Years -	Dana-Farber Cancer Institute
Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in NDMM	NCT04653246	Multiple Myelom... Newly Diagnosed... Autologous Stem...	Isatuximab Lenalidomide Bortezomib Inje... Dexamethasone	75 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for high dose therapy (hdt)