A Study of JNJ-54767414 (Daratumumab) in Combination With Bortezomib and Dexamethasone (D-Vd) in Japanese Participants With Relapsed or Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT02497378|
Recruitment Status : Active, not recruiting
First Posted : July 14, 2015
Last Update Posted : March 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: JNJ-54767414 (Daratumumab) Drug: Bortezomib Drug: Dexamethasone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||July 10, 2015|
|Estimated Primary Completion Date :||May 31, 2018|
|Estimated Study Completion Date :||May 31, 2018|
Experimental: JNJ-54767414 (Daratumumab) +Bortezomib+Dexamethasone
Participants 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.
Drug: JNJ-54767414 (Daratumumab)
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.Drug: Bortezomib
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.
Other Name: VELCADEDrug: Dexamethasone
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.
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Approximately 2 years ]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.
- Minimum Observed Serum Concentration (Cmin) of JNJ-54767414 (Daratumumab) [ Time Frame: Approximately 2 years ]The Cmin is the maximum observed serum concentration of JNJ-54767414.
- Maximum Observed Serum Concentration (Cmax) of JNJ-54767414 (Daratumumab) [ Time Frame: Approximately 2 years ]The Cmax is the maximum observed serum concentration of JNJ-54767414.
- Serum Concentration of JNJ-54767414 (Daratumumab) Antibodies [ Time Frame: Approximately 2 years ]Serum levels of antibodies to Daratumumab for evaluation of potential immunogenicity.
- Percentage of Participants With Overall Response Rate (ORR) [ Time Frame: Approximately 2 years ]Overall response rate is defined as the percentage of participants who achieve complete response or partial response according to the International Myeloma Working Group criteria, during or after study treatment.
- Percentage of Participants with Complete Response (CR) or better [ Time Frame: Approximately 2 years ]CR is Defined as the proportion of Participants achieving CR (including sCR) according to the IMWG criteria.
- Percentage of Participants with a Very Good Partial Response (VGPR) or better [ Time Frame: Approximately 2 years ]VGPR is defined as a greater than 90% reduction in serum myeloma protein (M-protein) plus urine myeloma protein less than 100 milligram (mg) per 24 hours.
- Time to Response [ Time Frame: Approximately 2 years ]Time to response is defined as the time from the date of first dose of study treatment to the date of the first documentation of observed response (CR or PR).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497378
|Study Director:||Janssen Pharmaceutical K.K. Clinical Trial||Janssen Pharmaceutical K.K.|