The primary purpose of this study for Part 1 (Dose Escalation) is to identify the safe effective dose (recommended Phase 2 doses [RP2Ds]) and schedule for JNJ-79635322 treatment regimen in combination with daratumumab with or without lenalidomide or with pomalidomide; and for Part 2 (Dose Expansion) is to further characterize the safety and tolerability of JNJ-79635322 combination treatment regimens at selected RP2D(s).

A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide or in Combination With Pomalidomide for Multiple Myeloma

Multiple Myeloma

Kahler's Disease

Blood Cancer

Hematologic Neoplasms

Hematologic Malignancies

Hematology

Hematological Malignancies

Daratumumab

Lenalidomide

Pomalidomide

JNJ-79635322

A Phase 1b Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide or in Combination With Pomalidomide for Multiple Myeloma

DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.

An AE is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.

Participants with clinically significant laboratory abnormalities (hematology and chemistry) will be reported.

Overall response rate is defined as percentage of participants who have a partial response (PR) or better evaluated by the investigator as per international myeloma working group (IMWG) 2016 criteria.

DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), as per IMWG 2016 response criteria, or death due to progression, whichever occurs first.

TTR is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant has met all criteria for PR or better as defined by IMWG 2016 response criteria.

Serum samples will be analyzed to determine concentrations of JNJ-79635322 and daratumumab.

AUCinf for JNJ-79635322 and daratumumab will be reported.

AUC(0-t) for JNJ-79635322 and daratumumab will be reported.

AUCtau for JNJ-79635322 and daratumumab will be reported.

Cmax for JNJ-79635322 and daratumumab will be reported.

T1/2 for JNJ-79635322 and daratumumab will be reported.

Tmax for JNJ-79635322 and daratumumab will be reported.

CL/F for JNJ-79635322 and daratumumab will be reported.

Vss/F for JNJ-79635322 and daratumumab will be reported.

Participants with anti-drug antibodies to JNJ-79635322 and daratumumab will be reported.

Participants who have received 1-3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (Treatment regimen A1) will receive a dose of JNJ-79635322 along with daratumumab to establish the recommended phase 2 doses (RP2D[s]) of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Based on the study evaluation team (SET) decision, enrollment may proceed in participants with newly diagnosed multiple myeloma (NDMM) (Treatment regimen A2/C). Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.

Participants who have received greater than or equal to (>=)1 prior line of therapy, including a PI and lenalidomide, and are lenalidomide refractory or >=2 prior lines of therapy, including a PI and lenalidomide will receive a dose of JNJ-79635322 along with pomalidomide to establish the RP2D(s) of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.

Participants with NDMM will receive a dose of JNJ-79635322 along with daratumumab and lenalidomide to establish the RP2D[s] of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens.

The primary purpose of this study for Part 1 (Dose Escalation) is to identify the safe
effective dose (recommended Phase 2 doses [RP2Ds]) and schedule for JNJ-79635322
treatment regimen in combination with daratumumab with or without lenalidomide or with
pomalidomide; and for Part 2 (Dose Expansion) is to further characterize the safety and
tolerability of JNJ-79635322 combination treatment regimens at selected RP2D(s).

Monash Medical Centre

St Vincents Hospital Melbourne

Peter MacCallum Cancer Centre

Calvary Mater Newcastle Hospital

Wollongong Hospital

Carmel Medical Center

Hadassah Medical Center

Sheba Medical Center

Tel Aviv Sourasky Medical Center

VU Medisch Centrum

Universitair Medisch Centrum Groningen

UMC Utrecht

Hosp. Clinic de Barcelona

Hosp Clinico Univ de Salamanca

DLTs are specific adverse events and are defined as any of the following: high grade
non-hematologic toxicity, or hematologic toxicity.

An AE is any untoward medical occurrence in a clinical study participant that does not
necessarily have a causal relationship with the pharmaceutical/biological agent under
study. Severity will be graded according to the national cancer institute common
terminology criteria for adverse events (NCI-CTCAE) version 5.0. Severity scale ranges
from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3=
severe, Grade 4= life-threatening and Grade 5= death related to adverse event.

Participants with clinically significant laboratory abnormalities (hematology and
chemistry) will be reported.

Overall response rate is defined as percentage of participants who have a partial
response (PR) or better evaluated by the investigator as per international myeloma
working group (IMWG) 2016 criteria.

DOR is defined as time from date of initial documentation of a response (PR or better) to
date of first documented evidence of progressive disease (PD), as per IMWG 2016 response
criteria, or death due to progression, whichever occurs first.

TTR is defined as the time between date of first dose of study treatment and the first
efficacy evaluation at which the participant has met all criteria for PR or better as
defined by IMWG 2016 response criteria.

Serum samples will be analyzed to determine concentrations of JNJ-79635322 and
daratumumab.

Participants who have received 1-3 prior lines of therapy, including a proteasome
inhibitor (PI) and an immunomodulatory drug (Treatment regimen A1) will receive a dose of
JNJ-79635322 along with daratumumab to establish the recommended phase 2 doses (RP2D[s])
of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Based on the study
evaluation team (SET) decision, enrollment may proceed in participants with newly
diagnosed multiple myeloma (NDMM) (Treatment regimen A2/C). Dose escalation and
de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants
will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s)
determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability
of the combination treatment regimens.

Participants who have received greater than or equal to (>=)1 prior line of therapy,
including a PI and lenalidomide, and are lenalidomide refractory or >=2 prior lines of
therapy, including a PI and lenalidomide will receive a dose of JNJ-79635322 along with
pomalidomide to establish the RP2D(s) of the JNJ-79635322 during Part 1 (Dose Escalation)
of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part
2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment
regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine
the safety and tolerability of the combination treatment regimens.

Participants with NDMM will receive a dose of JNJ-79635322 along with daratumumab and
lenalidomide to establish the RP2D[s] of the JNJ-79635322 during Part 1 (Dose Escalation)
of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part
2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment
regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine
the safety and tolerability of the combination treatment regimens.

A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide or in Combination With Pomalidomide for Multiple Myeloma

Trials at a glance

Trials at a glance

A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide or in Combination With Pomalidomide for Multiple Myeloma

Outcome measures

Primary outcome measures

Secondary outcome measures