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A Phase 2, Open-Label, Multicenter Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants with High-Risk Multiple Myeloma
Cancer Categories
Hematologic (Blood Cancers)
Karmanos Trial ID
2024-015
NCT ID
NCT06550895
Age Group
Adult
Scope
National
Phase
Phase II
Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
Phase II
Principal Investigator
Abhinav
Deol, M.D.
Oncology - Hematology, Oncology - Medical
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Objective:
Primary Objectives:
To characterize the safety of cilta-cel and talquetamab
Secondary Objectives
To evaluate the efficacy of cilta-cel and talquetamab
To characterize MRD-negativity
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
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
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
800-527-6266
Applicable Disease Site
Applicable Disease Site
Multiple Myeloma
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
CAR-T, Chemotherapy, Immunotherapy
Drugs
Ciltacabtagene Autoleucel; Cyclophosphamide; Daratumumab; Dexamethasone; Fludarabine Phosphate; Talquetamab; lenalidomide
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