A Study of Venetoclax Plus Lenalidomide and Dexamethasone for the Treatment of Newly Diagnosed t(11;14)-Positive Multiple Myeloma in Subjects Who Are Ineligible for High-Dose Therapy
|ClinicalTrials.gov Identifier: NCT03785184|
Recruitment Status : Suspended (Safety)
First Posted : December 24, 2018
Last Update Posted : March 21, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: venetoclax Drug: lenalidomide Drug: dexamethasone||Phase 2|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Multicenter, Single Arm, Open Label Study of Venetoclax Plus Lenalidomide and Dexamethasone for the Treatment of Newly Diagnosed t(11;14)-Positive Multiple Myeloma in Subjects Who Are Ineligible for High-Dose Therapy|
|Estimated Study Start Date :||April 29, 2019|
|Estimated Primary Completion Date :||May 16, 2022|
|Estimated Study Completion Date :||July 21, 2027|
Experimental: Venetoclax + Lenalidomide + Dexamethasone
Venetoclax up to 800 mg orally every day (QD) QD on Days 1 - 28 plus lenalidomide up to 25 mg orally QD on Days 1 - 21 (28 day cycle) plus dexamethasone up to 40 mg orally once weekly (QW).
Other Name: ABT-199
Other Name: Revlimid
- Percentage of Participates Who Achieve CR [ Time Frame: From baseline up to approximately 24 months ]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.
- Percent of Participants Who Achieve MRD Negativity [ Time Frame: From baseline up to approximately 24 months ]Minimal residual disease (MRD) negative after treatment is described as less than one myeloma cell per 100,000 bone marrow cells.
- Percent of Participants Who Achieve VGPR or Better [ Time Frame: From baseline up to approximately 24 months ]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.
- Overall Response Rate (ORR) [ Time Frame: From baseline up to approximately 24 months ]
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 to Response (TTR) [ Time Frame: From baseline up to approximately 24 months ]Time to response is defined as the time from randomization to the first response (CR, stringent complete response [sCR], VGPR, PR).
- Duration of response (DOR) [ Time Frame: Approximately 7 years ]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.
- Progression-free Survival (PFS) [ Time Frame: Approximately 7 years ]PFS is defined as time from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first.
- Minimal Residual Disease (MRD) Negativity Rate at 12 Months [ Time Frame: Approximately 12 months after initial dose of study drug ]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 to Disease Progression (TTP) [ Time Frame: Approximately 7 years ]TTP is defined as the time from start of treatment to disease progression, with deaths from causes other than progression censored.
- Time to Next Treatment (TTNT) [ Time Frame: Approximately 7 years ]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.
- Overall Survival (OS) Rate [ Time Frame: Approximately 7 years ]OS was defined as the time from the date the participant was randomized to the date of death.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03785184
|United States, California|
|Marin Cancer Care /ID# 208476|
|Greenbrae, California, United States, 94904|
|University of California, Los Angeles /ID# 208516|
|Los Angeles, California, United States, 90095|
|United States, Michigan|
|Karmanos Cancer Institute /ID# 208805|
|Detroit, Michigan, United States, 48201|
|Henry Ford Hospital /ID# 208481|
|Detroit, Michigan, United States, 48202|
|United States, North Carolina|
|Duke University Hospital /ID# 208306|
|Durham, North Carolina, United States, 27710|
|United States, Pennsylvania|
|UPMC Hillman Cancer Ctr /ID# 208121|
|Pittsburgh, Pennsylvania, United States, 15232|
|Australia, New South Wales|
|Westmead Hospital /ID# 210267|
|Westmead, New South Wales, Australia, 2145|
|Australia, South Australia|
|Flinders Centre for Innovation /ID# 210697|
|Adelaide, South Australia, Australia, 5042|
|St. Vincents Hosp Melbourne /ID# 210266|
|Fitzroy, Victoria, Australia, 3065|
|Austin Hospital /ID# 210268|
|Heidelberg, Victoria, Australia, 3084|
|Monash Medical Centre /ID# 210269|
|Melbourne, Victoria, Australia, 3168|
|Tom Baker Cancer Centre /ID# 208549|
|Calgary, Alberta, Canada, T2N 4N2|
|Princess Margaret Cancer Centr /ID# 208923|
|Toronto, Ontario, Canada, M5G 2M9|
|Hopital Maisonneuver-Rosemont /ID# 208550|
|Montreal, Quebec, Canada, H1T 2M4|
|McGill Univ HC /ID# 208486|
|Montreal, Quebec, Canada, H3G 1A4|
|Clinica Universitar de Navarra - Pamplona /ID# 209883|
|Pamplona, Navarra, Comunidad, Spain, 31008|
|Hospital Clinic de Barcelona /ID# 209888|
|Barcelona, Spain, 08036|
|Hspital Universitario Gregorio Maranon /ID# 209926|
|Madrid, Spain, 28009|
|Clinica Universitar de Navarra - Madrid /ID# 210131|
|Madrid, Spain, 28021|
|Hosp Univ 12 de Octubre /ID# 209887|
|Madrid, Spain, 28041|
|Hospital Univ Dr. Peset /ID# 209884|
|Valencia, Spain, 46017|
|Study Director:||AbbVie Inc.||AbbVie|