A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (KarMMa-9) KARMMA-9

What's the purpose of this trial?

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).

This is an upcoming trial that has not yet started accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

* 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.

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.

Additional Trial Information

Phase 3

Enrollment: 618 patients (estimated)

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Trial Locations

All Trial Locations

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Banner MD Anderson Cancer Center at Banner Gateway Medical Center

Gilbert, AZ

Not Yet Accepting

Mayo Clinic (Arizona)

Phoenix, AZ

Not Yet Accepting


University of California Irvine Medical Center

Orange, CA

Not Yet Accepting

University of California Davis Comprehensive Cancer Center

Sacramento, CA

Not Yet Accepting



Yale Cancer Center Smilow Cancer Hospital at Yale-New Haven

New Haven, CT

Not Yet Accepting


Mayo Clinic (Jacksonville)

Jacksonville, FL

Not Yet Accepting

Advent Health Cancer Institute (Orlando)

Orlando, FL

Not Yet Accepting

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Not Yet Accepting


Winship Cancer Institute Emory University

Atlanta, GA

Not Yet Accepting

Northside Hospital (Atlanta)

Atlanta, GA

Not Yet Accepting


Massachusetts General Hospital

Boston, MA

Not Yet Accepting

Boston Medical Center

Boston, MA

Not Yet Accepting


University of Michigan Comprehensive Cancer Center Rogel Cancer Center

Ann Arbor, MI

Not Yet Accepting

Ascension Providence Hospital (Southfield)

Southfield, MI

Not Yet Accepting


Mayo Clinic (Rochester)

Rochester, MN

Not Yet Accepting


Washington University School of Medicine

Saint Louis, MO

Not Yet Accepting

New York

North Carolina

Wake Forest Baptist - Comprehensive Cancer Center Atrium Health

Winston-Salem, NC

Not Yet Accepting




MD Anderson Cancer Center The University of Texas

Houston, TX

Not Yet Accepting
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