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).

A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma

Multiple Myeloma

Kahler's Disease

Blood Cancer

Hematologic Neoplasms

Hematologic Malignancies

Hematology

Hematological Malignancies

Talquetamab

Cilta-cel

A Phase 2, Open-Label, Multicenter Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma

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.

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.

The percentage of participants who achieve a VGPR or better response according to the
IMWG response criteria will be reported.

The percentage of participants with best overall response of CR or sCR will be reported
according to IMWG criteria.

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.

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.

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 is measured from the date of the first study treatment to the date of
the participant's death.

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.

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.

Participants with relapsed and/or refractory multiple myeloma (RRMM) will be administered
Cilta-cel followed by multiple cycles of talquetamab consolidation treatment and will be
followed up until death, lost to follow-up, consent withdrawal, or study end, whichever
occurs first.

A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma

Trials at a glance

Trials at a glance

A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma

Outcome measures

Primary outcome measures

Secondary outcome measures