Phase 1b/2: Isatuximab, Iberdomide, Bortezomib, Dexamethasone in Transplant Ineligible/Deferred Newly Diagnosed Myeloma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT07601100
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Newly Diagnosed Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Isatuximab — DRUG
    Administration, pre-medications and supportive care per protocol
  • Iberdomide — DRUG
    Administration, pre-medications and supportive care per protocol
  • Bortezomib — DRUG
    Administration, pre-medications and supportive care per protocol
  • Dexamethesone — DRUG
    Administration, pre-medications and supportive care per protocol

Study Details

This study is to evaluate the combination of isatuximab, iberdomide, bortezomib, and dexamethasone in newly diagnosed multiple myeloma participants who are transplant ineligible or not intended for upfront transplant. The names of the study drugs used in this research study are: isatuximab, iberdomide, bortezomib dexamethasone

Key Dates

Start date
Jun 26, 2026
Status verified
May 2026
Primary completion
Jul 1, 2029
Completion
Jul 1, 2034

Study Design

Enrollment
88 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A Induction: Age <70 years and Fit (standard-intensity schedule)
    Participants \<70 years of age and considered fit based on the myeloma frailty score of 0. Induction cycles 1-8; 28-day cycles: Isatuximab: 10 mg/kg Intravenous (IV) Days 1, 8, 15, 22 (Cycle 1 only); Days 1,15 (Cycle 2+) Iberdomide: 1 mg or 0.75 mg Oral (PO) Days 1-21 Bortezomib: 1.3 mg/m2 Subcutaneous (SC) Days 1, 8, 15, 22 Dexamethasone: 20 mg IV or PO Days 1, 2, 8, 9, 15, 16, 22, 23
  • Experimental: Group B Induction: Age ≥70 years and/or Intermediate Fit/Frail (reduced-intensity schedule)
    Participants ≥70 years of age and/or considered intermediate fitness and frail based on the myeloma frailty score of \>1. Induction cycles 1-8; 28-day cycles: Isatuximab: 10 mg/kg IV Days 1, 8, 15, 22 (Cycle 1 only); Days 1,15 (Cycle 2+) Iberdomide: 1 mg or 0.75 mg PO Days 1-21 Bortezomib: 1.3 mg/m2 SC Days 1, 8, 15 Dexamethasone: 12 mg IV or PO Days 1, 8, 15, 22; 8 mg IV or PO Days 2, 9, 16, 23
  • Experimental: Group A Maintenance: High-Risk, Age <70 years and Fit (3-drug schedule)
    Participants high-risk per IMWG/IMS criteria, \<70 years of age, considered fit based on the myeloma frailty score of 0. Maintenance cycles 1-36; 28-day cycles: (for participants with ≥PR after Induction Cycle 8) Isatuximab: 10 mg/kg IV Days 1, 15 Iberdomide: 1 mg or 0.75 mg PO Days 1-21 Bortezomib: 1.3 mg/m2 SC Days 1, 15
  • Experimental: Group A Maintenance: Standard-Risk, Age <70 years and Fit (2-drug schedule)
    Participants standard-risk per IMWG/IMS criteria, \<70 years of age, considered fit based on the myeloma frailty score of 0. Maintenance cycles 1-36; 28-day cycles: (for participants with ≥PR after Induction Cycle 8) Isatuximab: 10 mg/kg IV Days 1, 15 Iberdomide: 1 mg or 0.75 mg PO Days 1-21
  • Experimental: Group B Maintenance: High-Risk, Age ≥70 years and/or Intermediate Fit/Frail (3-drug schedule)
    Participants high-risk per IMWG/IMS criteria, ≥70 years of age and/or considered intermediate fitness and frail based on the myeloma frailty score of \>1. Maintenance cycles 1-36; 28-day cycles: (for participants with ≥PR after Induction Cycle 8) Isatuximab: 10 mg/kg IV Days 1, 15 Iberdomide: 1 mg or 0.75 mg PO Days 1-21 Bortezomib: 1.3 mg/m2 SC Days 1, 15
  • Experimental: Group B Maintenance: Standard-Risk, Age ≥70 years and/or Intermediate Fit/Frail (2-drug schedule)
    Participants standard-risk per IMWG/IMS criteria, ≥70 years of age and/or considered intermediate fitness and frail based on the myeloma frailty score of \>1. Maintenance cycles 1-36; 28-day cycles: (for participants with ≥PR after Induction Cycle 8) Isatuximab: 10 mg/kg IV Days 1, 15 Iberdomide: 1 mg or 0.75 mg PO Days 1-21

Primary Outcome Measure

Dose-limiting Toxicities (DLT) by Age-Frailty Group [Phase Ib] [ Time Frame: Assessed continuously during induction cycle 1, up to day 28 + 30 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical Center (BIDMC)BostonMassachusetts02215
Yuxin Liu, MD
[email protected]
617-632-3823
David Avigan, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Yuxin Liu, MD
[email protected]
617-632-3823
Yuxin Liu, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Beth Israel Deaconess Medical Center (BIDMC)· Boston, MADana-Farber Cancer Institute· Boston, MA

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