CAR- PRISM (PRecision Intervention Smoldering Myeloma)

Running, not enrolling · Phase 2

Conditions studied: Multiple Myeloma, Smoldering Multiple Myeloma

In brief

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)

Key facts

Study ID

NCT05767359

Run by

Dana-Farber Cancer Institute

People needed

20

Starts

2023-04-19

Expected to finish

2040-01-15

Last updated by the study team

2026-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years.
• High-risk SMM with ≤40% plasma cells in the bone marrow and with high-risk criteria defined as having 1 of the following 2 criteria:
• High-risk per "20-2-20" Criteria defined as presence of any two of the following:
• Serum M-protein ≥ 2 gm/dL
• Involved to uninvolved free light chain (FLC) ratio≥ 20
• Bone marrow PC% ≥ 20% to <40%.
• OR total score of 9 using the following scoring system:
• FLC Ratio
• >10-25 = 2
• >25-40 = 3
• > 40 = 5
• Serum M-protein (g/dL)
• >1.5-3 = 3
• >3 = 4
• BMPC%
• >15-20 = 2
• >20-30 = 3
• >30-40 = 5
• >40 = 6
• FISH abnormality (t(4,14), t(14,16), 1q gain, or del13q = 2
• Presence of ≥10% BMPC and at least one of the following:
• Evolving pattern:
• eMP (≥10% increase in serum M-protein ) over a 6 month period OR;
• Evolving change in hemoglobin (eHb) ≥ 0.5 g/dl decrease over a 12 months period OR;
• Progressive Involved light chain increase >10% over a 6 month period along with a light chain ration > 8

You may not qualify if…

• Prior SMM directed therapy.
• Symptomatic Multiple Myeloma or any evidence of CRAB criteria, including presence of myeloma defining events (MDE). Any prior therapy for active Myeloma should also be excluded. Bisphosphonates are not excluded.
• Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational. Prior therapy with bisphosphonate is allowed. Prior radiation therapy to a solitary plasmacytoma is allowed but had to be at least 1 year prior to enrollment on the trial. Prior clinical trials or therapy for smoldering MM or MGUS are not allowed per exclusion criteria described above.
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
• Diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low-risk prostate cancer after curative therapy.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, inflammatory disorders, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Plans to father a child while enrolled in this study or within 1 year after receiving the last dose of study drug.
• Pregnant or breast-feeding or planning to become pregnant while enrolled in this study or within 1 year after receiving the last dose of study drug.
• Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) or SARS-CoV-2 (COVID-19).
• Participants who are seropositive because of hepatitis B virus vaccine are eligible.
• Participants who are positive for SARS-COV-2 antibody, HIV1 and 2 antibody, hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.
• Participants who are positive for HIV1 or 2 infections, with undetectable viral load and on stable antiretrovirals, will not be excluded.
• Participants with past HCV infection that have now cleared will not be excluded.
• Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to Investigator's Brochure and appropriate package inserts).
• Prior or concurrent exposure to any of the following:
• 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.
• Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI and lumbar cytology are required.
• Myelodysplastic syndrome or active malignancies (i.e., progressing or requiring treatment change in the last 24 months). The only allowed exceptions are:

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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