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

Running, not enrolling · Phase 3

Conditions studied: Multiple Myeloma

In brief

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).

Key facts

Study ID

NCT06045806

Run by

Celgene

People needed

79

Starts

2023-10-16

Expected to finish

2029-11-20

Last updated by the study team

2026-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants aged ≥18 with Newly Diagnosed Multiple Myeloma (NDMM) who has received induction therapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT), without subsequent consolidation or maintenance. EXCEPTION: Participant received ≤ 7 days of lenalidomide (LEN) maintenance therapy and the investigator documents that there is no impact to the overall benefit/risk assessment due to the temporary interruption of LEN.
• Participant must have received 4 to 6 cycles of induction therapy, which must contain at a minimum an immunomodulatory drugs (IMiD) and a proteasome inhibitor (PI) (with or without anti-CD38 monoclonal antibody) and must have had a single ASCT 80 to 120 days prior to consent. Note: Participant must not have confirmed progression since commencing induction.
• Participant must have documented response of PR or VGPR at time of consent.
• Participant must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (participants with ECOG 2 due to pain because of underlying myeloma-associated bone lesions are eligible per investigator's discretion).
• Participant must have recovered to ≤ Grade 1 for any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy.

You may not qualify if…

• Participant with known central nervous system involvement with myeloma.
• Participant has non-secretory MM.
• Participant has systemic and uncontrolled fungal, bacterial, viral, or other infection.
• Participant has history of primary immunodeficiency.
• Participant has previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or B-cell maturation antigen targeted therapy.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Where it is running

• Local Institution - 0126 — Orange, California, United States
• Local Institution - 0113 — Sacramento, California, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• AdventHealth Orlando — Orlando, Florida, United States
• Local Institution - 0121 — Atlanta, Georgia, United States
• Local Institution - 0104 — Atlanta, Georgia, United States
• Local Institution - 0151 — Boston, Massachusetts, United States
• Ascension Providence Hospital — Southfield, Michigan, United States
• M Health Fairview Clinics and Surgery Center — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Columbia University Irving Medical Center — New York, New York, United States
• Novant Health Cancer Institute - Elizabeth — Charlotte, North Carolina, United States
• The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• Local Institution - 0132 — Philadelphia, Pennsylvania, United States
• Local Institution - 0124 — Austin, Texas, United States
• Local Institution - 0109 — Houston, Texas, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Local Institution - 0007 — Camperdown, New South Wales, Australia
• Local Institution - 0005 — Brisbane, Queensland, Australia
• Local Institution - 0004 — Melbourne, Victoria, Australia
• Local Institution - 0006 — Melbourne, Victoria, Australia
• Local Institution - 0008 — Melbourne, Victoria, Australia
• Local Institution - 0131 — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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