Who is eligible for clinical trial NCT06045806?

Participants must meet protocol criteria for Multiple Myeloma. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06045806 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-03-04

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)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Celgene

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (7 items).

Location: Local Institution - 0131 — Los Angeles, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria
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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (101 Sites)

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

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗