A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis
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|ClinicalTrials.gov Identifier: NCT03201965|
Recruitment Status : Active, not recruiting
First Posted : June 28, 2017
Results First Posted : March 4, 2021
Last Update Posted : October 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Amyloidosis||Drug: Cyclophosphamide Drug: Bortezomib Drug: Dexamethasone, 40 mg Drug: Daratumumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||416 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis|
|Actual Study Start Date :||October 5, 2017|
|Actual Primary Completion Date :||February 14, 2020|
|Estimated Study Completion Date :||August 2, 2024|
Active Comparator: CyBorD alone (cyclophosphamide/bortezomib/dexamethasone)
Participants will receive dexamethasone (40 milligrams [mg] orally or intravenous [IV] dose), followed by cyclophosphamide (300 milligram per meter square [mg/m^2] orally or IV dose), then bortezomib (1.3 mg/m^2 subcutaneous injection) weekly on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles.
Participants will receive 300 mg/m^2 of cyclophosphamide as an oral or IV dose.
Participants will receive 1.3 mg/m^2 of bortezomib as an subcutaneous (SC) injection.
Drug: Dexamethasone, 40 mg
Participants of CyBorD alone arm will receive 40 mg dexamethasone orally or IV dose. Participants of CyBorD plus daratumumab arm will receive dexamethasone 20 mg orally or IV dose as premedication and 20 mg on the day after daratumumab dosing to make a total of 40 mg.
Experimental: CyBorD plus Daratumumab
Participants will receive dexamethasone (20 mg orally or IV dose as premedication and 20 mg on the day after daratumumab dosing) followed by 1800 mg of daratumumab subcutaneously followed by cyclophosphamide (300 mg/m^2 orally or IV dose weekly) and bortezomib (1.3 mg/m^2 subcutaneous injection weekly) on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles. Daratumumab will be administered weekly for the first 8 weeks (2 cycles), then every 2 weeks for 4 cycles (cycles 3-6), and then every 4 weeks until progression of disease or subsequent therapy for a maximum of 2 years.
Participants will receive 1800 mg of daratumumab subcutaneously.
- Percentage of Participants With Overall Complete Hematologic Response (CHR) [ Time Frame: Up to 2.4 years ]Overall CHR rate was defined as percentage of participants who achieved CHR, according to the International Amyloidosis Consensus Criteria. CHR: normalization of free light chain levels and ratio, negative serum, and urine immunofixation. If involved free light chain (iFLC) is less than (<) upper limit of normal (ULN) and serum and urine Immunofixation electrophoresis (IFE) are negative, then neither a normal uninvolved free light chain (uFLC) level nor a normal free light chain (FLC) ratio are required for complete response (CR).
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): NCT03201965
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|