A Phase 2, Open-Label, Multicenter Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma MONUMENTAL-8
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What's the purpose of this trial?

The purpose of this study is to define the safety of Ciltacabtagene Autoleucel (Cilta-cel) and Talquetamab in participants with high-risk multiple myeloma (MM).

This trial is currently open and 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:

* Documented diagnosis of MM according to the IMWG diagnostic criteria and is defined as a measurable disease at screening
* Cohorts 1 and 3: Received at least 3 prior lines of antimyeloma therapy and have undergone greater than or equal to (\>=) 1 complete cycle of the therapy. Cohort 2: Be newly diagnosed MM and considered ineligible for high-dose chemotherapy with autologous stem cell transplant (ASCT)
* Cohorts 1 and 3: Documented evidence of progression of disease (PD) or failure to achieve a response to the last line of therapy
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Participant of childbearing potential (POCBP) must have a negative pregnancy test using a highly sensitive β-human chorionic gonadotropin (hCG) serum pregnancy test at screening

Exclusion Criteria:

* Cohorts 1 and 3: Prior treatment with chimeric antigen receptor T cell (CAR-T) therapy directed at any target or any prior B cell maturation antigen (BCMA)-directed therapy/prior G protein-coupled receptor family C Group 5 member D (GPRC5D)-directed therapy. Cohort 2: Received any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids
* Cohorts 1 and 3: Received either of the following: An allogenic stem cell transplant within 6 months before apheresis/first dose of study drug and no immunosuppressive medications administered before the start of study treatment. And secondly, received an autologous stem cell transplant less than (\<)12 weeks before apheresis/first dose of study treatment
* Cohort 2: Received a strong cytochrome P450 (CYP450) inducer within 5 half-lives prior to daratumumab, lenalidomide and dexamethasone (DRd) induction therapy
* Receive live, attenuated vaccine within 4 weeks of enrollment
* Toxicity from previous anticancer therapy not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy

Additional Trial Information

Phase 2

Enrollment: 30 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

UCSF Helen Diller Comprehensive Cancer Center University of California San Francisco

San Francisco, CA

Temporarily Suspended

Iowa

Holden Comprehensive Cancer Center - University of Iowa University of Iowa Hospitals and Clinics

Iowa City, IA

Open and Accepting

Kentucky

Norton Cancer Institute (St. Matthews) St. Matthews Campus

Louisville, KY

Open and Accepting

Michigan

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Temporarily Suspended

Pennsylvania

Thomas Jefferson University Hospital

Philadelphia, PA

Temporarily Suspended

Abramson Cancer Center - University of Pennsylvania (UPENN) University of Pennsylvania

Philadelphia, PA

Not Yet Accepting

Utah

Huntsman Cancer Institute University of Utah

Salt Lake City, UT

Not Yet Accepting

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Temporarily Suspended
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