Trial Outcomes & Findings for A Study of JNJ-63723283, an Anti-programmed Death-1 Monoclonal Antibody, Administered in Combination With Daratumumab, Compared With Daratumumab Alone in Participants With Relapsed or Refractory Multiple Myeloma (NCT NCT03357952)

Last Updated: 2025-02-04

Results Overview

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are adverse events (AEs) which will occur up to 2 years that were absent before treatment or that worsened relative to pre-treatment state.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

10 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2025-02-04

Participant Flow

A total of 10 participants were enrolled in the study. Among these, 9 participants were included in the Safety Run-in phase (Part 1) who received daratumumab intravenous (IV) and JNJ-63723283 IV and 1 participant randomized to Arm A in Part 2 of the study who received daratumumab IV alone.

Participant milestones

Participant milestones
Measure	Part 1: Daratumumab + JNJ-63723283 Participants in Safety Run-in cohort received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards) and JNJ-63723283 240 mg IV during Week 1 on Cycle 1 Day 2, Cycle 1 Day 15, then every 2 weeks thereafter. Each treatment cycle consisted of 28 days. Participants continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.	Part 2: Daratumumab (Arm A) Participants in treatment Arm A received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards). All participants were continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.
Overall Study STARTED	9	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	9	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Daratumumab + JNJ-63723283 Participants in Safety Run-in cohort received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards) and JNJ-63723283 240 mg IV during Week 1 on Cycle 1 Day 2, Cycle 1 Day 15, then every 2 weeks thereafter. Each treatment cycle consisted of 28 days. Participants continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.	Part 2: Daratumumab (Arm A) Participants in treatment Arm A received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards). All participants were continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.
Overall Study Withdrawal by Subject	0	1
Overall Study Sponsor Decision	9	0

Baseline Characteristics

A Study of JNJ-63723283, an Anti-programmed Death-1 Monoclonal Antibody, Administered in Combination With Daratumumab, Compared With Daratumumab Alone in Participants With Relapsed or Refractory Multiple Myeloma

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Up to 2 years

Population: Safety analysis set included all participants who have received at least 1 dose of study agent (JNJ-63723283 or daratumumab, partial or complete) in safety run-in phase of the study.

Outcome measures

Outcome measures
Measure	Part 1: Daratumumab + JNJ-63723283 n=9 Participants Participants in Safety Run-in cohort received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards) and JNJ-63723283 240 mg IV during Week 1 on Cycle 1 Day 2, Cycle 1 Day 15, then every 2 weeks thereafter. Each treatment cycle consisted of 28 days. Participants continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.
Number of Participants With Treatment Emergent Adverse Events (TEAE) in Safety run-in Phase (Part 1)	9 Participants

PRIMARY outcome

Timeframe: Cycle 1 (28 days)

Population: Safety analysis set included all participants who have received at least 1 dose of study agent (JNJ-63723283 or daratumumab, partial or complete) in safety run-in phase.

Dose limiting toxicity defined as an adverse event or adverse drug reaction experienced by the participants during observation of 28 days (Part 1) of treatment Cycle 1.

Outcome measures

Outcome measures
Measure	Part 1: Daratumumab + JNJ-63723283 n=9 Participants Participants in Safety Run-in cohort received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards) and JNJ-63723283 240 mg IV during Week 1 on Cycle 1 Day 2, Cycle 1 Day 15, then every 2 weeks thereafter. Each treatment cycle consisted of 28 days. Participants continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.
Number of Participants With Dose Limiting Toxicity in Safety run-in Phase (Part 1)	0 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: Safety analysis set included all participants who have received at least 1 dose of study agent in Part 2 of the study.

Outcome measures

Outcome measures
Measure	Part 1: Daratumumab + JNJ-63723283 n=1 Participants Participants in Safety Run-in cohort received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards) and JNJ-63723283 240 mg IV during Week 1 on Cycle 1 Day 2, Cycle 1 Day 15, then every 2 weeks thereafter. Each treatment cycle consisted of 28 days. Participants continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.
Number of Participants With Treatment Emergent Adverse Events (TEAE) in Part 2	1 Participants

Adverse Events

Part 1: Daratumumab + JNJ-63723283

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Part 2: Daratumumab (Arm A)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: Daratumumab + JNJ-63723283 n=9 participants at risk Participants in Safety Run-in cohort received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards) and JNJ-63723283 240 mg IV during Week 1 on Cycle 1 Day 2, Cycle 1 Day 15, then every 2 weeks thereafter. Each treatment cycle consisted of 28 days. Participants continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.	Part 2: Daratumumab (Arm A) n=1 participants at risk Participants in treatment Arm A received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards). All participants were continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.
Blood and lymphatic system disorders Febrile Neutropenia	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Infections and infestations Septic Shock	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Nervous system disorders Encephalitis Autoimmune	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Renal and urinary disorders Acute Kidney Injury	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years

Other adverse events

Other adverse events
Measure	Part 1: Daratumumab + JNJ-63723283 n=9 participants at risk Participants in Safety Run-in cohort received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards) and JNJ-63723283 240 mg IV during Week 1 on Cycle 1 Day 2, Cycle 1 Day 15, then every 2 weeks thereafter. Each treatment cycle consisted of 28 days. Participants continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.	Part 2: Daratumumab (Arm A) n=1 participants at risk Participants in treatment Arm A received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards). All participants were continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.
Blood and lymphatic system disorders Anaemia	33.3% 3/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Blood and lymphatic system disorders Leukopenia	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Blood and lymphatic system disorders Lymphopenia	22.2% 2/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Blood and lymphatic system disorders Neutropenia	44.4% 4/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Blood and lymphatic system disorders Thrombocytopenia	33.3% 3/9 • Up to 2 years	100.0% 1/1 • Up to 2 years
Cardiac disorders Bradycardia	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Ear and labyrinth disorders Vertigo	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Eye disorders Corneal Degeneration	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Gastrointestinal disorders Constipation	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Gastrointestinal disorders Diarrhoea	22.2% 2/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Gastrointestinal disorders Dry Mouth	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Gastrointestinal disorders Dyspepsia	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Gastrointestinal disorders Nausea	33.3% 3/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Gastrointestinal disorders Vomiting	33.3% 3/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
General disorders Asthenia	22.2% 2/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
General disorders Chills	22.2% 2/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
General disorders Fatigue	33.3% 3/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
General disorders Influenza Like Illness	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
General disorders Oedema Peripheral	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
General disorders Pyrexia	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Infections and infestations Body Tinea	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Infections and infestations Cellulitis	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Infections and infestations Herpes Simplex	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Infections and infestations Osteomyelitis	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Infections and infestations Rhinitis	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Infections and infestations Upper Respiratory Tract Infection	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Infections and infestations Viral Upper Respiratory Tract Infection	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Infections and infestations Vulvovaginal Candidiasis	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Investigations Lipase Increased	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Investigations Weight Decreased	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Metabolism and nutrition disorders Dehydration	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Metabolism and nutrition disorders Folate Deficiency	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Metabolism and nutrition disorders Hyperamylasaemia	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Metabolism and nutrition disorders Hyperglycaemia	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Metabolism and nutrition disorders Hypomagnesaemia	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Musculoskeletal and connective tissue disorders Back Pain	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Musculoskeletal and connective tissue disorders Muscle Atrophy	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Musculoskeletal and connective tissue disorders Muscle Spasms	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Musculoskeletal and connective tissue disorders Myalgia	33.3% 3/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Musculoskeletal and connective tissue disorders Myopathy	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Nervous system disorders Dizziness	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Nervous system disorders Paraesthesia	22.2% 2/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Renal and urinary disorders Proteinuria	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Respiratory, thoracic and mediastinal disorders Cough	22.2% 2/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Respiratory, thoracic and mediastinal disorders Dysphonia	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Respiratory, thoracic and mediastinal disorders Epistaxis	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Respiratory, thoracic and mediastinal disorders Throat Irritation	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Skin and subcutaneous tissue disorders Pruritus	11.1% 1/9 • Up to 2 years	0.00% 0/1 • Up to 2 years
Vascular disorders Hypertension	22.2% 2/9 • Up to 2 years	0.00% 0/1 • Up to 2 years

Additional Information

Executive Medical Director

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER

Measure	Part 1: Daratumumab + JNJ-63723283 n=9 Participants Participants in Safety Run-in cohort received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards) and JNJ-63723283 240 mg IV during Week 1 on Cycle 1 Day 2, Cycle 1 Day 15, then every 2 weeks thereafter. Each treatment cycle consisted of 28 days. Participants continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.	Part 2: Daratumumab (Arm A) n=1 Participants Participants in treatment Arm A received daratumumab 16 mg/kg IV once every week (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards). All participants were continued to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria were met.	Total n=10 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 10.97 • n=5 Participants	43 years n=7 Participants	61 years STANDARD_DEVIATION 12.12 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Belgium	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Israel	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Spain	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants