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A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

NCT06045806 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2026-03-05

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).

Conditions

Interventions

BIOLOGICAL

idecabtagene vicleucel

Specified dose on specified days

DRUG

Lenalidomide

Specified dose on specified days

DRUG

Fludarabine

Specified dose on specified days

DRUG

Cyclophosphamide

Specified dose on specified days

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • 2seventy bio

    collaborator INDUSTRY

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-16
Primary Completion
2025-08-11
Completion
2029-11-20
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Japan
  • Norway
  • Poland
  • Romania
  • South Korea
  • Spain
  • United Kingdom

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 NCT06045806 on ClinicalTrials.gov