Active — Not RecruitingPhase 2

CAR- PRISM (PRecision Intervention Smoldering Myeloma)

United States20 participantsStarted 2023-04-19

Plain-language summary

The goal of this research study is to test if ciltacabtagene autoleucel (cilta-cel) is safe and effective in treating participants with high-risk, smoldering myeloma. The names of the treatment interventions used in this study are: * Cilta-cel (or chimeric antigen receptor T cells) * Cyclophosphamide (a lymphodepleting chemotherapy) * Fludarabine (a lymphodepleting chemotherapy)

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. High-risk per "20-2-20" Criteria defined as presence of any two of the following:
✓. Presence of ≥10% BMPC and at least one of the following:

Exclusion criteria

✕. Teclistamab, Belantamab, or any anti-BCMA therapy
✕. Investigational vaccine within 4 weeks of study therapy
✕. Live, attenuated vaccine within 4 weeks of study therapy.
✕. Monoclonal antibody therapy within 21 days except for those unrelated to MM therapy such as rituximab or other monoclonal antibodies for RA for example.
✕. Cytotoxic therapy within 14 days of study therapy
✕. PI therapy within 14 days of study therapy
✕. IMiD agent therapy within 14 days of study therapy
✕. Radiotherapy within 14 days or focal radiation within 7 days of study therapy.

What they're measuring

Incidence of Dose Limiting Toxicities (DLT)

Timeframe: 24 months

Nature of Dose Limiting Toxicities (DLT)

Timeframe: 24 months

Incidence of Adverse Events (AEs)

Timeframe: 24 months

Trial details

NCT IDNCT05767359

SponsorDana-Farber Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-15

View on ClinicalTrials.gov More Multiple Myeloma trials