A Study of JNJ-54767414 (Daratumumab) in Combination With Bortezomib and Dexamethasone (D-Vd) in Japanese Participants With Relapsed or Refractory Multiple Myeloma
A Phase 1b Study of JNJ-54767414 (Daratumumab) in Combination With Bortezomib and Dexamethasone (D-Vd) in Japanese Patients With Relapsed or Refractory Multiple Myeloma (MM)
2 other identifiers
interventional
8
1 country
5
Brief Summary
The purpose of this study is to evaluate the tolerability and safety of JNJ-54767414 (daratumumab) in Combination With Bortezomib and Dexamethasone (D-Vd) in Japanese participants with relapsed (the return of a medical problem) or refractory (not responding to treatment) multiple myeloma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 multiple-myeloma
Started Jul 2015
Shorter than P25 for phase_1 multiple-myeloma
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2015
CompletedStudy Start
First participant enrolled
July 10, 2015
CompletedFirst Posted
Study publicly available on registry
July 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2018
CompletedMarch 7, 2019
February 1, 2019
2.7 years
July 10, 2015
March 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was 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. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Approximately 2 years
Secondary Outcomes (7)
Minimum Observed Serum Concentration (Cmin) of JNJ-54767414 (Daratumumab)
Approximately 2 years
Maximum Observed Serum Concentration (Cmax) of JNJ-54767414 (Daratumumab)
Approximately 2 years
Serum Concentration of JNJ-54767414 (Daratumumab) Antibodies
Approximately 2 years
Percentage of Participants With Overall Response Rate (ORR)
Approximately 2 years
Percentage of Participants with Complete Response (CR) or better
Approximately 2 years
- +2 more secondary outcomes
Study Arms (1)
JNJ-54767414 (Daratumumab) +Bortezomib+Dexamethasone
EXPERIMENTALParticipants will be administered JNJ-54767414 (daratumumab) intravenously at a dose of 16 milligram per kilogram (mg/kg) weekly for the first 3 cycles, then on Day 1 of Cycles 4-8 (every 3 weeks), and then on Day 1 of subsequent cycles (every 4 weeks), First 8 Cycles are 21-day cycles; Cycles 9 and onwards are 28-day cycles. Bortezomib at a dose of 1.3 milligram per meter square (mg/m\^2) subcutaneously (SC) on Days 1, 4, 8 and 11 of each 21-day cycle for 8 treatment cycles and Dexamethasone orally at 20 mg on Day 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 bortezomib treatment cycles.
Interventions
JNJ-54767414 (Daratumumab) will be administered as an Intravenous (IV) infusion at a dose of 16 milligram per kilogram (mg/kg) weekly for the first 3 cycles, on Day 1 of Cycles 4-8 (every 3 weeks), and then on Day 1 of subsequent cycles (every 4 weeks). First 8 Cycles are 21-day cycles; Cycles 9 and onwards are 28-day cycles.
Bortezomib will be administered at a dose of 1.3 mg/m\^2 subcutaneously (SC) on Day 1, 4, 8 and 11 of each 21-day cycle. Eight Bortezomib treatment cycles are to be administered.
Dexamethasone will be administered orally at 20 mg on Day 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 bortezomib treatment cycles (except for Cycles 1-3). In Cycles 1-3, participants receive dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11, 12 and 15. During weeks when the participants receives an infusion of daratumumab, dexamethasone will be administered at a dose of 20 mg IV or orally (PO) (only if IV is not available) before the daratumumab infusion as preinfusion medication.
Eligibility Criteria
You may qualify if:
- Participants proven to have symptomatic (having symptoms) multiple myeloma (MM) according the International Myeloma Working Group (IMWG) diagnostic criteria
- Participant must have documented MM as defined by following criteria: Monoclonal plasma cells in the bone marrow 10 percent (%), or presence of a biopsy-proven plasmacytoma at some point in their disease history, disease measurements: a) Serum M-protein greater than or equal to (\>=) 1 gram per deciliter (g/dL) (\>=10 gram per liter \[g/L\]) b) Serum immunoglobulin A \[IgA\] M-protein \>= 0.5 g/dL); c) Urine M-protein \>=200 milligram per 24 hour (mg/24 h); d) Serum immunoglobulin free light chain \>=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
- Participant must have received at least 1 prior line of therapy for MM
- Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Participant must have achieved a response (partial response \[PR\] or better based on investigator's determination of response by the IMWG criteria) to at least 1 prior regimen
You may not qualify if:
- Participant has received daratumumab or other anti-cluster of differentiation 38 (anti-CD38) therapies previously
- Is refractory to bortezomib or another PI, like ixazomib and carfilzomib (had progression of disease while receiving bortezomib therapy or within 60 days of ending bortezomib therapy or another PI therapy, like ixazomib and carfilzomib
- Is intolerant to bortezomib (ie, discontinued due to any adverse event while on bortezomib treatment)
- Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of daratumumab first administration. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 milligram per day \[mg/day\] for a maximum of 4 days) before treatment. A list of anti-myeloma treatments with the corresponding pharmacokinetic half-lives is provided in the Site Investigational Product Procedures Manual (IPPM)
- Has a history of malignancy (other than multiple myeloma) within 3 years before the date of daratumumab first administration
- Has any concurrent medical condition or disease (eg, active systemic infection, pulmonary impairment) that is likely to interfere with study procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
Hiroshima, Japan
Unknown Facility
Hitachi, Japan
Unknown Facility
Nagoya, Japan
Unknown Facility
Shibuya City, Japan
Unknown Facility
Tachikawa, Japan
Related Publications (1)
Iida S, Ichinohe T, Shinagawa A, Suzuki K, Takezako N, Aoki M. Safety and efficacy of daratumumab in combination with bortezomib and dexamethasone in Japanese patients with relapsed or refractory multiple myeloma. Int J Hematol. 2018 Apr;107(4):460-467. doi: 10.1007/s12185-017-2390-2. Epub 2017 Dec 19.
PMID: 29260507DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Pharmaceutical K.K. Clinical Trial
Janssen Pharmaceutical K.K.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2015
First Posted
July 14, 2015
Study Start
July 10, 2015
Primary Completion
March 6, 2018
Study Completion
March 6, 2018
Last Updated
March 7, 2019
Record last verified: 2019-02