MedTrace Logo

Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone in NDMM

NCT04653246 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-04-30

No results posted yet for this study

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.

Conditions

  • Multiple Myeloma
  • Newly Diagnosed Multiple Myeloma (NDMM)
  • Autologous Stem Cell Transplant

Interventions

DRUG

Isatuximab

Via IV at predetermined dosage and predetermined days during each cycle

DRUG

Lenalidomide

Oral, predetermined dosage and predetermined days during each cycle

DRUG

Bortezomib Injection

SQ Oral, predetermined dosage and predetermined days during each cycle

DRUG

Dexamethasone

IV or Oral predetermined dosage and predetermined days during each cycle

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Jacob Laubach, MD

    lead OTHER

Principal Investigators

  • Jacob C Laubach, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-13
Primary Completion
2025-12-15
Completion
2029-01-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT04653246 on ClinicalTrials.gov