Multiple Myeloma
Conditions
Brief summary
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).
Interventions
DRUGCilta-cel
Cilta-cel infusion will be administered intravenously.
DRUGTalquetamab
Talquetamab will be administered subcutaneously.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented diagnosis of MM according to the IMWG diagnostic criteria and is defined as a measurable disease at screening * Cohort 1: Received at least 3 prior lines of antimyeloma therapy and have undergone greater than or equal to (\>=) 1 complete cycle of the therapy * Cohort 1: 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
* Cohort 1: 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 1: 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 * 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 * Stroke, transient ischemic attack, or seizure within 6 months of signing informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AE) by Severity According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 | Up to 3 years and 5 months | An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non-investigational) product. It does not necessarily have a causal relationship with the investigational product. The severity of AEs has 5 grades based on NCI-CTCAE version 5.0 criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Overall Response (OR) | Up to 3 years and 5 months | The percentage of participants who have a partial response (PR) or better response according to the International Myeloma Working Group (IMWG) response criteria will be reported. |
| Percentage of Participants with Very Good Partial Response (VGPR) or Better | Up to 3 years and 5 months | The percentage of participants who achieve a VGPR or better response according to the IMWG response criteria will be reported. |
| Percentage of Participants with Complete Response (CR) or Stringent Complete Response (sCR) | Up to 3 years and 5 months | The percentage of participants with best overall response of CR or sCR will be reported according to IMWG criteria. |
| Duration of Response (DOR) | Up to 3 years and 5 months | DOR is defined as the time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease (PD) (defined in the IMWG response criteria) or death due to any cause, whichever occur first. |
| Time to Response (TTR) | Upto 3 years and 5 months | TTR is defined as the time between date of the first study treatment and the first efficacy evaluation that the participant met all criteria for PR or better. |
| Progression Free Survival (PFS) | Up to 3 years and 5 months | PFS is defined as the time from the date of the first study treatment to the date of first documented disease progression (defined in the IMWG response criteria), or death due to any cause, whichever occurs first. |
| Overall Survival | Up to 3 years and 5 months | Overall Survival is measured from the date of the first study treatment to the date of the participant's death. |
| Percentage of Participants with Minimal Residual Disease (MRD) Negativity | Up to 3 years and 5 months | The percentage of participants who achieve MRD-negativity at a threshold of 10\^-5 at any timepoint after the date of the first study treatment and before disease progression or start of any subsequent antimyeloma therapy will be reported. |
| Percentage of Participants with Sustained MRD-Negativity | Up to 3 years and 5 months | The percentage of participants who sustained MRD-negative status, as determined by next generation sequencing (NGS) with sensitivity of 10\^-5, for at least 6 months without examination showing MRD-positive or PD in between will be reported. |
Countries
Australia, United States
Contacts
STUDY_DIRECTORJanssen Research & Development, LLC Clinical trial
Janssen Research & Development, LLC
Outcome results
None listed