This study will evaluate the safety and preliminary efficacy of venetoclax when combined with lenalidomide and dexamethasone for participants with newly diagnosed, active t(11;14) positive multiple myeloma (MM). This study will consist of 2 parts: Part 1 Dose Escalation and Part 2 Dose Expansion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
City of Hope /ID# 212211
Duarte, California, United States
Percentage of Participates Who Achieve CR
Complete response (CR) is defined as negative immunofixation of serum and urine, and disappearance of any soft tissue plasmacytomas, and \< 5% plasma cells in bone marrow.
Time frame: From baseline up to approximately 24 months
Percent of Participants Who Achieve MRD Negativity
Minimal residual disease (MRD) negative after treatment is described as less than one myeloma cell per 100,000 bone marrow cells.
Time frame: From baseline up to approximately 24 months
Percent of Participants Who Achieve VGPR or Better
Very Good Partial Response (VGPR) per international myeloma working group (IMWG) criteria is defined as serum or urine myeloma protein (m-protein) detectable by immunofixation but not on electrophoresis, or greater than or equal to 90% reduction in serum m-protein and urine m-protein less than 100 mg/24 hours.
Time frame: From baseline up to approximately 24 months
Overall Response Rate (ORR)
ORR is described as the percentage of participants who experience partial response (PR) or better; PR per IMWG is described as follows: * ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M protein by ≥ 90% or to \< 200 mg/24 h * If the serum and urine M-protein are not measurable, a decrease ≥ 50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria * If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, ≥ 50% reduction in bone marrow plasma cells is required in place of M-protein, provided baseline percentage was ≥ 30% * In addition, if present at baseline, ≥ 50% reduction in size of soft tissue plasmacytomas is also required
Time frame: From baseline up to approximately 24 months
Time to Response (TTR)
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Marin Cancer Care /ID# 208476
Greenbrae, California, United States
University of California, Los Angeles /ID# 208516
Los Angeles, California, United States
Karmanos Cancer Institute /ID# 208805
Detroit, Michigan, United States
Henry Ford Hospital /ID# 208481
Detroit, Michigan, United States
Duke University Hospital /ID# 208306
Durham, North Carolina, United States
UPMC Hillman Cancer Ctr /ID# 208121
Pittsburgh, Pennsylvania, United States
Westmead Hospital /ID# 210267
Westmead, New South Wales, Australia
Flinders Centre for Innovation /ID# 210697
Bedford Park, South Australia, Australia
St. Vincents Hosp Melbourne /ID# 210266
Fitzroy, Victoria, Australia
...and 12 more locations
Time to response is defined as the time from randomization to the first response (CR, stringent complete response \[sCR\], VGPR, PR).
Time frame: From baseline up to approximately 24 months
Duration of response (DOR)
DOR is defined as the time from first observation of PR to the time of disease progression, with deaths from causes other than progression censored.
Time frame: Approximately 7 years
Progression-free Survival (PFS)
PFS is defined as time from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first.
Time frame: Approximately 7 years
Minimal Residual Disease (MRD) Negativity Rate at 12 Months
Percent of participants meeting the MRD Negative criteria at 12 months after initial dose; MRD Negative defined as less than one myeloma cell per 100,000 bone marrow cells.
Time frame: Approximately 12 months after initial dose of study drug
Time to Disease Progression (TTP)
TTP is defined as the time from start of treatment to disease progression, with deaths from causes other than progression censored.
Time frame: Approximately 7 years
Time to Next Treatment (TTNT)
The time to next treatment is defined as the time between the date of the first study drug intake and the date of the first next treatment intake after study drug discontinuation.
Time frame: Approximately 7 years
Overall Survival (OS) Rate
OS was defined as the time from the date the participant was randomized to the date of death.
Time frame: Approximately 7 years