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A Phase 1b/2 Study of the Combination Isatuximab, Iberdomide, Bortezomib, and Dexamethasone in Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible or Not Intended for Upfront Transplant

NCT07601100 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-05-22

No results posted yet for this study

Summary

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

Conditions

  • Newly Diagnosed Multiple Myeloma

Interventions

DRUG

Arm A: Isatuximab, iberdomide, bortezomib, and dexamethasone with a standard-intensity bortezomib and dexamethasone schedule

Drug: Isatuximab (IV infusion), per protocol Drug: Iberdomide/CC-220 (oral capsule), per protocol Drug: Bortezomib (subcutaneous injection), per protocol Drug: Dexamethasone (oral tablet and/or IV per protocol), per protocol Premedications prior to isatuximab (per protocol): diphenhydramine, acetaminophen, H2 blocker (e.g., ranitidine per protocol), montelukast, and dexamethasone (route per protocol)

DRUG

Arm B: Isatuximab, iberdomide, bortezomib, and dexamethasone with a reduced-intensity bortezomib and dexamethasone schedule

Drug: Isatuximab (IV infusion), per protocol Drug: Iberdomide/CC-220 (oral capsule), per protocol Drug: Bortezomib (subcutaneous injection), per protocol Drug: Dexamethasone (oral tablet and/or IV per protocol), per protocol Premedications prior to isatuximab (per protocol): diphenhydramine, acetaminophen, H2 blocker (e.g., ranitidine per protocol), montelukast, and dexamethasone (route per protocol)

Sponsors & Collaborators

Principal Investigators

  • Yuxin Liu, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-26
Primary Completion
2029-07-01
Completion
2034-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07601100 on ClinicalTrials.gov