A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM)
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|ClinicalTrials.gov Identifier: NCT03984097|
Recruitment Status : Active, not recruiting
First Posted : June 12, 2019
Last Update Posted : March 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: TAK-079 Drug: Lenalidomide Drug: Dexamethasone Drug: Bortezomib||Phase 1|
The drug being tested in this study is called TAK-079. TAK-079 is being tested to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) when added to 1 of 2 standard backbone regimens (LenDex or VRd) with newly diagnosed NDMM for whom stem cell transplantation (SCT) is not planned as initial therapy.
The study will enroll approximately 36 participants. Participants will be non-randomly assigned to one of the two treatment groups:
- TAK-079 and LenDex
- TAK-079 and VRd
This multi-center trial will be conducted in the United States. The overall time to participate in this study is 36 months. Participants will have a follow-up visit 30 days after the last dose of study drug or before the start of subsequent alternative anticancer therapy, to permit the detection of any delayed AEs.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Multicenter Phase 1b Study Investigating the Safety of TAK-079 in Combination With Backbone Regimens for the Treatment of Patients With Newly Diagnosed Multiple Myeloma and for Whom Stem Cell Transplantation Is Not Planned as Initial Therapy|
|Actual Study Start Date :||July 29, 2019|
|Estimated Primary Completion Date :||August 30, 2021|
|Estimated Study Completion Date :||May 29, 2023|
Experimental: TAK-079 and LenDex
TAK-079, subcutaneously, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter, along with lenalidomide, orally, once daily for 21 days and dexamethasone, orally or intravenously, once on Days 1, 8, 15 and 22 in each 28-day treatment until progressive disease (PD) or unacceptable toxicity, withdrawal of consent, death, or termination of the study by sponsor for up to Month 36. The dosage of dexamethasone can be reduced for participants who are greater than (>) 75 years, have poorly controlled diabetes, or had prior intolerance to or AE from corticosteroid therapy.
Experimental: TAK-079 and VRd
TAK-079 subcutaneously, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter, along with bortezomib, subcutaneously, once on Days 1, 8, and 15, for a maximum of 8 cycles, lenalidomide, orally, once daily for 21 days, and dexamethasone, orally or intravenously, once on Days 1, 8, 15 and 22 in each 28-day treatment until PD or unacceptable toxicity, withdrawal of consent, death, or termination of the study by sponsor for up to Month 36. The dosage of dexamethasone can be reduced for participants who are >75 years, have poorly controlled diabetes, or had prior intolerance to or AE from corticosteroid therapy.
- RP2D of TAK-079 [ Time Frame: Up to Cycle 1 (Cycle length is equal to [=] 28 days) ]RP2D of TAK-079 along with lenalidomide-dexamethasone (LenDex) or TAK-079 along with bortezomib, lenalidomide, and dexamethasone (VRd) will be based on number of participants with dose limiting toxicity (DLT). DLTs will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
- Overall Response Rate (ORR) [ Time Frame: Up to Month 36 ]ORR based on International Myeloma Working Group (IMWG) Uniform Response Criteria, is defined as the percentage of participants who achieved a PR or better during the study. PR is defined as greater than or equal to (>=) 50 percent (%) reduction of serum M-protein, and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 milligram per 24 hours (mg/24 h). If serum and urine M protein are not measurable, >=50% decrease in difference between involved and uninvolved free light chain (FLC) levels is required in place of M protein criteria.
- Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: From first dose up to 30 days after the last dose of study drug (up to Month 36) ]
- Number of Participants With Grade 3 or Higher TEAEs [ Time Frame: From first dose up to 30 days after the last dose of study drug (up to Month 36) ]Adverse event (AE) Grades will be evaluated as per NCI CTCAE, version 4.03.
- Number of Participants with TEAEs Leading to Treatment Discontinuation [ Time Frame: From first dose up to 30 days after the last dose of study drug (up to Month 36) ]
- Number of Participants With AEs Leading to On-study Deaths [ Time Frame: From screening up to 30 days after the last dose of study drug (up to Month 36) ]
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): NCT03984097
|United States, Alabama|
|Birmingham, Alabama, United States, 35211|
|United States, California|
|Pacific Cancer Care|
|Monterey, California, United States, 93940|
|United States, Maryland|
|American Oncology Partners of Maryland, PA|
|Bethesda, Maryland, United States, 20817|
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|United States, North Carolina|
|Levine Cancer Institute|
|Charlotte, North Carolina, United States, 28204|
|United States, Ohio|
|Good Samaritan Hospital|
|Cincinnati, Ohio, United States, 45220|
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Wisconsin|
|Froedtert and The Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Study Director:||Medical Director||Millennium Pharmaceuticals, Inc.|