Clinical trial NCT03357952: 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
Official title: A Randomized, Open-label, Multicenter, Multiphase Study of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, Administered in Combination With Daratumumab, Compared With Daratumumab Alone in Subjects With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Multiple Myeloma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-11-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: This is a multi-phase study of JNJ-63723283 in combination with daratumumab compared with daratumumab alone in participants with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or whose disease is double refractory to both a PI and an IMiD. The study consists of Screening Phase (procedures performed within 28 days before enrollment), Open-Label Treatment Phase (with End-of-Treatment Visit to occur 4 weeks after the last dose of study treatment) and Follow-up phase (8 weeks after the last dose of study treatment). Ongoing safety evaluation during Part 1 and Part 2 will be overseen by the Safety Evaluation Team (SET). In Part 3, ongoing safety and efficacy evaluation will be performed by the Independent Data Monitoring Committee (IDMC).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE) in Safety run-in Phase (Part 1)
timeFrame: Up to 2 years
measure: Number of Participants With Dose Limiting Toxicity in Safety run-in Phase (Part 1)
timeFrame: Cycle 1 (28 days)
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE) in Part 2
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: ZNA Stuivenberg
city: Brasschaat
country: Belgium
facility: Algemeen Ziekenhuis Klina
city: Brugge
country: Belgium
facility: AZ St.-Jan Brugge-Oostende AV
city: Brussel
country: Belgium
facility: UZBrussel
city: Edegem
country: Belgium
facility: UZA
city: Gent
country: Belgium
facility: UZ Gent
city: Kortrijk
country: Belgium
facility: Az Groeninge
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Haifa
country: Israel
facility: Carmel Hospital
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
city: Badalona
country: Spain
facility: Hosp. Univ. Germans Trias I Pujol
city: Pamplona
country: Spain
facility: Clinica Univ. de Navarra
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: