A Study to Evaluate Dara-CyBorD in Previously Untreated and Relapsed Subjects With Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT02951819|
Recruitment Status : Active, not recruiting
First Posted : November 1, 2016
Last Update Posted : March 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Daratumumab Drug: Cyclophosphamide Drug: Bortezomib Drug: Dexamethasone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Daratumumab Plus Cyclophosphamide, Bortezomib and Dexamethasone (Dara-CyBorD) in Previously Untreated and Relapsed Subjects With Multiple Myeloma|
|Actual Study Start Date :||November 9, 2016|
|Actual Primary Completion Date :||March 8, 2018|
|Estimated Study Completion Date :||December 25, 2020|
U.S. FDA Resources
Subjects will receive Daratumumab along with Cyclophosphamide, Bortezomib and Dexamethasone (Dara-CyBorD) as induction on a 28-day cycle length and Daratumab and Dexamethasone on Day 1 of each cycle for 12 cycles as maintenance therapy.
For induction therapy cycle 1 day 1 and day 2 doses of daratumumab will be 8 milligram/kilogram (mg/kg). Starting cycle 1 week 2 until the completion of week 8 of daratumumab patients will receive 16 mg/kg Intravenously (IV) weekly.
Starting week 9 until the completion of week 24 therapy daratumumab will be administered every other week at 16 mg/kg IV.
Starting week 25 and beyond for induction therapy daratumumab will be given once every 4 weeks.
Subjects will receive 4 to 8 cycles of oral cyclophosphamide 300 milligram per meter square (mg/m^2 ) on Days 1, 8, 15, and 22 for every 28 days.Drug: Bortezomib
Subjects will receive 4 to 8 cycles of Bortezomib 1.5 mg/m2 subcutaneous (SC) on Days 1, 8, and 15 for every 28 days.Drug: Dexamethasone
Subjects will be given corticosteroids (Dexamethasone) as pre-infusion therapy prior to daratumumab and for the first 8 cycles will also receive post-infusion corticosteroids (Dexamethasone).
- Complete Response plus Very Good Partial (CR+VGPR) Response Rate [ Time Frame: Approximately 4 Months ]Percentage of subjects achieving complete response plus very good partial response rate (CR+VGPR) according to International Myeloma Working Group (IMWG) criteria.
- Overall Response Rate (ORR) [ Time Frame: Following 4 cycles (each cycle is of 28 days), end of induction (4-8 cycles), at start of maintenance therapy and after end of maintenance therapy (12 months) ]Percentage of subjects who achieve complete response (CR), very good partial response (VGPR) or partial response (PR) according to IMWG criteria.
- Time to Very Good Partial Response (VGPR) or Better [ Time Frame: Up to End of Treatment (Approximately 36 months) ]Time to VGPR or better is defined as the duration from the date of start of induction therapy to the date of initial documentation of VGPR or better, which is confirmed by a repeated measurement as required by the IMWG criteria.
- Time to Partial Response or Better [ Time Frame: Up to End of Treatment (Approximately 36 months) ]Time to partial response is defined as the duration from the date of start of induction therapy to the date of initial documentation of PR or better, which is confirmed by a repeated measurement as required by the IMWG criteria.
- Duration of Response (DoR) [ Time Frame: Up to End of Treatment (Approximately 36 months) ]Duration of response is defined as the duration from the date of initial documentation of a response (PR or better) according to the IMWG criteria to the date of first documented evidence of progressive disease according to the IMWG criteria.
- Progression Free Survival (PFS) Rate [ Time Frame: 36 Months (approximately at 1 year and 3 years) ]Percentage of subjects who have not developed progressive disease and are at alive at 1 year and 3 years after study entry.
- Overall Survival Rate [ Time Frame: 36 Months (approximately at 1 year and 3 years) ]Percentage of subjects who are alive at 1 year and 3 years after study entry.
- Number of Subjects with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to End of Treatment (Approximately 36 months) ]
- Infusion Reaction Profile of Split-Dose Infusions of Daratumumab [ Time Frame: Day 1 and Day 2 of Cycle 1 ]Infusion reaction profile of split-dose infusions of daratumumab administered as 8 mg/kg on C1D1 and C1D2 by tabulating the incidence of infusion-related reactions by System-Organ Class and preferred term.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951819
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|Study Director:||Janssen Scientific Affairs, LLC Clinical Trial||Janssen Scientific Affairs, LLC|