The purpose of this study is to evaluate how well JNJ-79635322 works when compared with teclistamab.

A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Multiple Myeloma

Kahler's Disease

Blood Cancer

Hematologic Neoplasms

Hematologic Malignancies

Hematology

Hematological Malignancies

Teclistamab

JNJ-79635322

A Phase 3 Randomized Study Comparing JNJ-79635322 Versus Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma After 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Antibody and Lenalidomide

CR or better is defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria during or after the study treatment.

PFS is defined as the duration from the date of randomization to either progressive disease (PD) or death, whichever comes first. Disease progression will be determined according to the IMWG response criteria.

ORR is defined as the percentage of participants who achieve partial response (PR) or better prior to subsequent antimyeloma therapy in accordance with the IMWG criteria.

VGPR or better is defined as the percentage of participants achieving VGPR, CR, or sCR prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or after the study treatment.

DoR is defined as the time interval between the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG response criteria or death due to any cause, whichever occurs first.

MRD-negative CR is defined as the percentage of participants with CR or better who achieve MRD-negative status, as determined by next-generation flow cytometry (NGF), at any time point after randomization and prior to PD or subsequent antimyeloma therapy.

MRD-negative CR at 1 year is defined as the percentage of participants who achieve MRD-negative status at 12 months as determined by NGF, prior to PD or subsequent antimyeloma therapy and who also achieve CR or better according to IMWG criteria.

MRD-negative CR at 5 years is defined as the percentage of participants who achieve MRD-negative status at 5 years as determined by NGF, prior to PD or subsequent antimyeloma therapy and who also achieve CR or better according to IMWG criteria.

PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first. Those who are alive and for whom a second disease progression has not been observed are censored at the last date of follow-up.

OS is defined as the time from the date of randomization to the date of the participant's death due to any cause.

TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment. Death due to progressive disease without the start of any subsequent antimyeloma therapy will be considered as an event.

An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. Any new or worsening AE occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent anticancer therapy will be considered treatment-related regardless of the start date of the event. TEAEs will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0. Severity scale ranges from Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, Grade 5= death related to adverse event.

Number of participants with abnormalities in laboratory parameters (serum chemistry, hematology, and urinalysis) will be reported.

Change from baseline in HRQoL, symptoms and functioning as assessed by MySIm-Q score will be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment with established content validity for participants with relapsed or refractory multiple myeloma (RRMM) and newly diagnosed MM.

Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported.

The EQ-5D-5L is a generic measure of health status that contains 5-item questionnaire that assesses 5 domains (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 dimensions are used to compute a single utility score, ranging from zero (0.0) to 1 (1.0), representing the general health status of the individual.

Time to worsening in HRQoL, symptoms and functioning using the MySIm-Q scale scores will be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment with established content validity for participants with RRMM and newly diagnosed MM.

Time to worsening in HRQoL, symptoms and functioning using the EORTC-QLQ-C30 score will be reported.

The MySIm-Q is a disease-specific PRO assessment with established content validity for participants with RRMM and newly diagnosed MM.

Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported.

The EORTC IL46 consists of one single question that measures global impression of burden due to treatment-related symptoms. The response options range from "not at all" to "very much" on a 4-point scale.

Participants will receive subcutaneous (SC) dose of JNJ-79635322 treatment of a finite duration or intolerable toxicity (whichever is first).

Participants will receive teclistamab as a SC injection until PD or intolerable toxicity.

The purpose of this study is to evaluate how well JNJ-79635322 works when compared with
teclistamab.

CR or better is defined as the percentage of participants achieving CR or stringent
complete response (sCR) prior to subsequent antimyeloma therapy in accordance with the
international myeloma working group (IMWG) criteria during or after the study treatment.

PFS is defined as the duration from the date of randomization to either progressive
disease (PD) or death, whichever comes first. Disease progression will be determined
according to the IMWG response criteria.

ORR is defined as the percentage of participants who achieve partial response (PR) or
better prior to subsequent antimyeloma therapy in accordance with the IMWG criteria.

VGPR or better is defined as the percentage of participants achieving VGPR, CR, or sCR
prior to subsequent antimyeloma therapy in accordance with the IMWG criteria during or
after the study treatment.

DoR is defined as the time interval between the date of initial documentation of a
response (PR or better) to the date of first documented evidence of progressive disease
according to the IMWG response criteria or death due to any cause, whichever occurs
first.

MRD-negative CR is defined as the percentage of participants with CR or better who
achieve MRD-negative status, as determined by next-generation flow cytometry (NGF), at
any time point after randomization and prior to PD or subsequent antimyeloma therapy.

MRD-negative CR at 1 year is defined as the percentage of participants who achieve
MRD-negative status at 12 months as determined by NGF, prior to PD or subsequent
antimyeloma therapy and who also achieve CR or better according to IMWG criteria.

MRD-negative CR at 5 years is defined as the percentage of participants who achieve
MRD-negative status at 5 years as determined by NGF, prior to PD or subsequent
antimyeloma therapy and who also achieve CR or better according to IMWG criteria.

PFS2 is defined as the time interval between the date of randomization and date of event,
which is defined as progressive disease as assessed by investigator on the first
subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first.
Those who are alive and for whom a second disease progression has not been observed are
censored at the last date of follow-up.

OS is defined as the time from the date of randomization to the date of the participant's
death due to any cause.

TTNT is defined as the time from randomization to the start of subsequent antimyeloma
treatment. Death due to progressive disease without the start of any subsequent
antimyeloma therapy will be considered as an event.

An AE is any untoward medical occurrence in a clinical study participant administered a
pharmaceutical (investigational or non investigational) product. Any new or worsening AE
occurring at or after the initial administration of study treatment through the day of
last dose plus 30 days or prior to the start of subsequent anticancer therapy will be
considered treatment-related regardless of the start date of the event. TEAEs will be
graded according to the National Cancer Institute-Common Terminology Criteria for Adverse
Events (NCI-CTCAE) Version 6.0. Severity scale ranges from Grade 1= mild, Grade 2=
moderate, Grade 3= severe, Grade 4= life-threatening, Grade 5= death related to adverse
event.

Number of participants with abnormalities in laboratory parameters (serum chemistry,
hematology, and urinalysis) will be reported.

Change from baseline in HRQoL, symptoms and functioning as assessed by MySIm-Q score will
be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment
with established content validity for participants with relapsed or refractory multiple
myeloma (RRMM) and newly diagnosed MM.

Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30
score will be reported.

The EQ-5D-5L is a generic measure of health status that contains 5-item questionnaire
that assesses 5 domains (mobility, self-care, usual activities, pain or discomfort, and
anxiety or depression) plus a visual analog scale rating "health today" with anchors
ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The
scores for the 5 dimensions are used to compute a single utility score, ranging from zero
(0.0) to 1 (1.0), representing the general health status of the individual.

Time to worsening in HRQoL, symptoms and functioning using the MySIm-Q scale scores will
be reported. The MySIm-Q is a disease-specific patient-reported outcome (PRO) assessment
with established content validity for participants with RRMM and newly diagnosed MM.

Time to worsening in HRQoL, symptoms and functioning using the EORTC-QLQ-C30 score will
be reported.

The MySIm-Q is a disease-specific PRO assessment with established content validity for
participants with RRMM and newly diagnosed MM.

Percentage of participants with meaningful improvement in symptoms, functioning, and
HRQoL as assessed by EORTC-QLQ-C30 score will be reported.

The EORTC IL46 consists of one single question that measures global impression of burden
due to treatment-related symptoms. The response options range from "not at all" to "very
much" on a 4-point scale.

Participants will receive subcutaneous (SC) dose of JNJ-79635322 treatment of a finite
duration or intolerable toxicity (whichever is first).

A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Trials at a glance

Trials at a glance

A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Outcome measures

Primary outcome measures

Secondary outcome measures