Phase 2
Completed N=86
A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma
Source: ClinicalTrials.gov NCT05347485 ↗Enrolled (actual)
86
Serious AEs
51.2%
Results posted
Dec 2024
Primary outcomePrimary: Overall Response Rate (ORR) — 57.3 Percentage of participants
Summary
The purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (OOS).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) |
57.3 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
81 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity |
1; 6; 14; 51; 9 | — |
| SECONDARY Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) |
42 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity (ICANS), Other Neurotoxicities, and Secondary Primary Malignancies |
61; 12; 8; 5 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Event of Special Interest (AESIs): Prolonged and Recurrent Cytopenias |
50; 42; 29; 1; 75; 36 | — |
| SECONDARY Number of Participants by Worst Grade Abnormalities in Clinical Laboratory Tests: Hematology (Including Coagulation) and Chemistry After Cilta-cel OOS Infusion |
1; 1; 9; 33; 39; 3 | — |
| SECONDARY Partial Response (PR) Rate |
9.8 | — |
| SECONDARY Very Good Partial Response (VGPR) Rate |
14.6 | — |
| SECONDARY Complete Response (CR) Rate |
17.1 | — |
| SECONDARY Clinical Benefit Rate (CBR) |
59.8 | — |
| SECONDARY Stringent Complete Response (sCR) Rate |
15.9 | — |
| SECONDARY Duration of Response (DOR) |
NA | — |
| SECONDARY Progression Free Survival (PFS) |
NA | — |
| SECONDARY Overall Survival (OS) |
NA | — |
| SECONDARY Minimal Residual Disease (MRD)-Negative Rate |
66.7; 66.7; 53.3 | — |
| SECONDARY Number of Participants With Presence of Replication Competent Lentivirus |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Eligible for treatment with cilta-cel per United States prescribing information (USPI) or locally approved label
- Participant is suffering from serious or life threatening multiple myeloma per USPI (or locally approved label, respectively), and re-apheresis, re-manufacturing, or other anti-myeloma directed therapies is not considered feasible or adequate per investigator
- Has adequate general health status and organ function per investigator assessment and meets the criteria to receive cilta-cel out-of-specifications (OOS)
- Meets the criteria to receive lymphodepleting chemotherapy
- A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test during screening and prior to the first dose of cyclophosphamide and fludarabine
Exclusion Criteria
- History of active uncontrolled infection or condition where an administration of cilta-cel OOS constitutes serious health risk to the participant
- Known allergies, hypersensitivity, or intolerance to the excipients of cilta-cel OOS including dimethyl sulfoxide (DMSO), dextran 40, or residual kanamycin per USPI
- Hepatitis B infection
- Hepatitis C infection defined as (anti hepatitis C virus [HCV] antibody positive or detectable HCV ribonucleic acid [RNA]) or known to have a history of hepatitis C
- Seropositive for human immunodeficiency virus (HIV)
- Uncontrolled autoimmune disease
Data sourced from ClinicalTrials.gov (NCT05347485). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.