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

NCT03357952 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: CR1083812017-002611-3454767414MMY2036
• Study Type: interventional
• Target: 10
• Locations: 3 countries
• Sites: 13

Brief Summary

The main purpose of this study is to assess the safety of the combination of JNJ-63723283 and daratumumab (Part 1); to compare the overall response rate (ORR) in participants treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone (Part 2); and to compare progression-free survival (PFS) in participants treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone (Part 3).

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment Emergent Adverse Events (TEAE) in Safety run-in Phase (Part 1)

  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.

  Up to 2 years

• Number of Participants With Dose Limiting Toxicity in Safety run-in Phase (Part 1)

  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.

  Cycle 1 (28 days)

Secondary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (TEAE) in Part 2

  Up to 2 years

Study Arms (2)

Part 1: JNJ-63723283 + Daratumumab

EXPERIMENTAL

Participants in Safety Run-in cohort will receive daratumumab IV and JNJ-63723283 IV for 1 cycle (28 days). Participants will continue to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria are met. Participants who were previously receiving JNJ-283 plus daratumumab have the opportunity to continue daratumumab therapy alone.

Drug: Daratumumab; Drug: JNJ-63723283

Part 2 and Part 3: Daratumumab/ JNJ-63723283 + Daratumumab

EXPERIMENTAL

Participants in Treatment Arm A will receive daratumumab IV and in Treatment Arm B will receive daratumumab IV and JNJ-63723283 IV for cycles of 28 days each. All participants will continue to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria are met. Participants who were previously receiving JNJ-283 plus daratumumab have the opportunity to continue daratumumab therapy alone.

Drug: Daratumumab; Drug: JNJ-63723283

Interventions

Daratumumab DRUG

Participants will receive daratumumab 16 milligram per kilogram (mg/kg) intravenously (IV) once every week for 8 weeks (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards).

Also known as: JNJ-54767414

Part 1: JNJ-63723283 + Daratumumab; Part 2 and Part 3: Daratumumab/ JNJ-63723283 + Daratumumab

JNJ-63723283 DRUG

Participants will receive JNJ-63723283 240 mg IV during Week 1 on Cycle 1 Day 2, Cycle 1 Day 15, then every 2 weeks thereafter.

Part 1: JNJ-63723283 + Daratumumab; Part 2 and Part 3: Daratumumab/ JNJ-63723283 + Daratumumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) in any order during the course of treatment for multiple myeloma or have disease that is refractory to both a PI and an IMiD
• Evidence of a response (partial response \[PR\] or better based on investigator's determination of response by International Myeloma Working Group \[IMWG\] criteria) to at least 1 prior treatment regimen
• Documented measurable disease for multiple myeloma at screening as defined in protocol
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
• Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies

You may not qualify if:

• Received any of the following prescribed medications or therapies in the past: Anti-CD38 antibody, including daratumumab, and/or Anti-PD-1 (programmed death-1) and anti-PD-L1 (programmed death-ligand 1) antibodies
• Plans to undergo a stem cell transplant prior to progression of disease on this study (these participants should not be enrolled to reduce disease burden prior to transplant)
• History of malignancy (other than multiple myeloma) within 2 years prior to first administration of study drug (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years)
• Clinical signs of meningeal involvement of multiple myeloma
• Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \<50% of predicted normal or known moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (13)

ZNA Stuivenberg

Antwerp, 2060, Belgium

Location

Algemeen Ziekenhuis Klina

Brasschaat, 2930, Belgium

Location

AZ St.-Jan Brugge-Oostende AV

Bruges, 8000, Belgium

Location

UZBrussel

Brussels, 1090, Belgium

Location

UZA

Edegem, 2650, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

Az Groeninge

Kortrijk, 8500, Belgium

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Carmel Hospital

Haifa, 34362, Israel

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916, Spain

Location

Clinica Univ. de Navarra

Pamplona, 31008, Spain

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

daratumumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Limitations and Caveats

Single participant enrolled in Part 2 was not evaluable for efficacy, hence data for Part 2 efficacy outcome measures was not collected. Sponsor suspended enrollment during Part 2, hence Part 2 stopped early, and Part 3 was not conducted.

Results Point of Contact

• Title: Executive Medical Director
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 30, 2017
• Study Start: November 16, 2017
• Primary Completion: October 24, 2018
• Study Completion: November 19, 2021
• Last Updated: February 4, 2025
• Results First Posted: November 12, 2019

Record last verified: 2025-01

Locations

IL (4); ES (2); BE (7)