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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Cilta-cel infusion will be administered intravenously.
Talquetamab will be administered subcutaneously.
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Icahn School of Medicine at Mount Sinai
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
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.
Time frame: Up to 3 years and 5 months
Percentage of Participants With Overall Response (OR)
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.
Time frame: Up to 3 years and 5 months
Percentage of Participants with Very Good Partial Response (VGPR) or Better
The percentage of participants who achieve a VGPR or better response according to the IMWG response criteria will be reported.
Time frame: Up to 3 years and 5 months
Percentage of Participants with Complete Response (CR) or Stringent Complete Response (sCR)
The percentage of participants with best overall response of CR or sCR will be reported according to IMWG criteria.
Time frame: Up to 3 years and 5 months
Duration of Response (DOR)
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 frame: Up to 3 years and 5 months
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New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Royal Prince Alfred Hospital
Camperdown, Australia
Austin Hospital
Heidelberg, Australia
Peter MacCallum Cancer Centre
Melbourne, Australia
The Alfred Hospital
Melbourne, Australia
Time to Response (TTR)
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.
Time frame: Upto 3 years and 5 months
Progression Free Survival (PFS)
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.
Time frame: Up to 3 years and 5 months
Overall Survival
Overall Survival is measured from the date of the first study treatment to the date of the participant's death.
Time frame: Up to 3 years and 5 months
Percentage of Participants with Minimal Residual Disease (MRD) Negativity
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.
Time frame: Up to 3 years and 5 months
Percentage of Participants with Sustained MRD-Negativity
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.
Time frame: Up to 3 years and 5 months