The purpose of this original study is to determine the recommended phase 2 dose (RP2D) of TAK-079 when administered to participants with NDMM in combination with the backbone treatment regimen. The purpose of the safety/access cohort is to provide continued access to TAK-079 to participants previously enrolled to a TAK-079 parent study and to evaluate the long-term safety profile of TAK-079.
Treatment phase 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 in the original study or Treatment Phase: * TAK-079 and LenDex * TAK-079 and VRd All enrolled participants will have the opportunity to complete the treatment therapy and then enter the Extension study for as long as participants continue to derive benefit. Safety Extension Phase participants who have previously received and tolerated TAK-079-based parent study will continue to the extension study. The study will also evaluate the long-term safety profile of TAK-079. Participants will continue to receive TAK-079 and, if applicable, SOC backbone therapy as per the parent study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
TAK-079 subcutaneously.
Lenalidomide orally.
Dexamethasone orally.
Alabama Oncology
Birmingham, Alabama, United States
Pacific Cancer Care
Monterey, California, United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, United States
Columbia University Medical Center
Treatment Phase: RP2D of TAK-079
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.
Time frame: Up to Cycle 1 (Cycle length is equal to [=] 28 days)
Safety Extension Phase: Number of Participants Reporting one or More Serious Adverse Events (SAEs)
Time frame: From first dose up to 30 days after the last dose of study drug (up to 4 years)
Safety Extension Phase: Number of Participants With Grade 3 or Higher Treatment-emergent Adverse Events (TEAEs)
Adverse event (AE) Grades will be evaluated as per NCI CTCAE, version 4.03.
Time frame: From first dose up to 30 days after the last dose of study drug (up to 4 years)
Safety Extension Phase: Number of Participants Who Require Dose Modification
Time frame: From first dose up to 30 days after the last dose of study drug (up to 4 years)
Safety Extension Phase: 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 4 years)
Treatment Phase: Overall Response Rate (ORR)
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.
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Bortezomib subcutaneously.
Pomalidomide orally.
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
MD Anderson Cancer Center
Houston, Texas, United States
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Time frame: Up to 2 years
Treatment Phase: Number of Participants Reporting one or More TEAEs and SAEs
Time frame: From first dose up to 30 days after the last dose of study drug (up to 2 years)
Treatment Phase: Number of Participants With Grade 3 or Higher TEAEs
AE Grades will be evaluated as per NCI CTCAE, version 4.03.
Time frame: From first dose up to 30 days after the last dose of study drug (up to 2 years)
Treatment Phase: 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 2 years)
Treatment Phase: 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 2 years)