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
Sponsor: Jacob Laubach, MD
This observational or N/A phase trial investigates Autologous Stem Cell Transplant and Multiple Myeloma and is currently ongoing. Jacob Laubach, MD leads this study, which shows 10 recorded versions since 2021 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)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.
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.
Status Flow
Change History
10 versions recorded-
May 4, 2026 — Present [daily]
Active Not Recruiting
Phase: PHASE2 → None
-
Jan 2026 — May 2026 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
-
Dec 2024 — Jan 2026 [monthly]
Recruiting PHASE2
-
Sep 2024 — Dec 2024 [monthly]
Recruiting PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE2
Status: Active Not Recruiting → Recruiting
▶ Show 5 earlier versions
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Feb 2024 — Jul 2024 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
-
Jul 2023 — Feb 2024 [monthly]
Recruiting PHASE2
-
Sep 2022 — Jul 2023 [monthly]
Recruiting PHASE2
-
Sep 2021 — Sep 2022 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
-
Jan 2021 — Sep 2021 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility Summary
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.
Contact Information
- Jacob Laubach, MD
- Sanofi
For direct contact, visit the study record on ClinicalTrials.gov .