deltatrials
Active Not Recruiting INTERVENTIONAL NCT04653246

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

Updated 10 times since 2021 Last updated: Apr 27, 2026 Started: Jul 13, 2021 Primary completion: Dec 15, 2025 Completion: Jan 13, 2029
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshotNot Yet Recruiting~Sep 2021 – ~Sep 2022 · 12 months · monthly snapshotRecruiting~Sep 2022 – ~Jul 2023 · 10 months · monthly snapshotRecruiting~Jul 2023 – ~Feb 2024 · 7 months · monthly snapshotRecruiting~Feb 2024 – ~Jul 2024 · 5 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~Jan 2026 · 13 months · monthly snapshotRecruiting~Jan 2026 – ~May 2026 · 4 months · monthly snapshotMay 4, 2026 – present · 3 months · daily API

Change History

10 versions recorded
  1. May 4, 2026 — Present [daily]

    Active Not Recruiting

    Phase: PHASE2None

  2. Jan 2026 — May 2026 [monthly]

    Active Not Recruiting PHASE2

    Status: RecruitingActive Not Recruiting

  3. Dec 2024 — Jan 2026 [monthly]

    Recruiting PHASE2

  4. Sep 2024 — Dec 2024 [monthly]

    Recruiting PHASE2

  5. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE2

    Status: Active Not RecruitingRecruiting

Show 5 earlier versions
  1. Feb 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE2

    Status: RecruitingActive Not Recruiting

  2. Jul 2023 — Feb 2024 [monthly]

    Recruiting PHASE2

  3. Sep 2022 — Jul 2023 [monthly]

    Recruiting PHASE2

  4. Sep 2021 — Sep 2022 [monthly]

    Recruiting PHASE2

    Status: Not Yet RecruitingRecruiting

  5. 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

Sponsor contact:
  • Jacob Laubach, MD
  • Sanofi
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations