Study Stopped
Strategic considerations
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
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
1 other identifier
interventional
N/A
4 countries
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2019
Shorter than P25 for phase_2 multiple-myeloma
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2018
CompletedFirst Posted
Study publicly available on registry
December 24, 2018
CompletedStudy Start
First participant enrolled
April 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2019
CompletedAugust 28, 2019
August 1, 2019
4 months
December 20, 2018
August 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From baseline up to approximately 24 months
Secondary Outcomes (10)
Percent of Participants Who Achieve MRD Negativity
From baseline up to approximately 24 months
Percent of Participants Who Achieve VGPR or Better
From baseline up to approximately 24 months
Overall Response Rate (ORR)
From baseline up to approximately 24 months
Time to Response (TTR)
From baseline up to approximately 24 months
Duration of response (DOR)
Approximately 7 years
- +5 more secondary outcomes
Study Arms (1)
Venetoclax + Lenalidomide + Dexamethasone
EXPERIMENTALVenetoclax 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).
Interventions
Eligibility Criteria
You may qualify if:
- Must have documented, confirmed active multiple myeloma (MM) with greater than or equal to 10% clonal bone marrow plasma cells or biopsy-proven bone or extramedullary plasmacytoma and any one or more of the following myeloma-defining events:
- Evidence of end organ damage attributed to the underlying plasma cell proliferative disorder and satisfying at least one of the protocol specified laboratory criteria for calcium elevation, renal failure, anemia, or lytic bone lesions; OR
- One or more of the biomarkers of malignancy as described in the protocol.
- Must have MM positive for the t(11;14) translocation, as determined by methods described in the protocol.
- Must have measurable disease defined by at least one of the following criteria:
- Serum M-protein ≥ 1.0 g/dL (immunoglobulin \[Ig\]G myeloma) or greater than or equal to 0.5 g/dL (IgA, IgM, IgD, or IgE myeloma);
- Urine M-protein greater than or equal to 200 mg/24 hours;
- Serum free light chain (FLC) greater than or equal to 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal.
- Newly diagnosed and not considered a candidate for high-dose therapy and hematopoietic stem cell transplantation (HSCT)
- Must have Eastern Cooperative Oncology Group performance status less than or equal to 2.
You may not qualify if:
- Has a co-existing condition as specified in the protocol.
- Has history of other active malignancies, including myelodysplastic syndromes (MDS) within the past 3 years with specific exceptions detailed in the protocol.
- Has been treated with or received any of the following:
- Prior or current systemic therapy or hematopoietic stem cell transplantation (HSCT) for MM (a short course of treatment with corticosteroids equivalent to dexamethasone 40 mg/day for a maximum of 4 days is allowed before treatment); use of systemic strong or moderate inhibitor or inducer of cytochrome P450(CYP)3A within 7 days before the first dose of study drug.
- Radiation therapy within 2 weeks of dosing
- Plasmapheresis within 4 weeks of dosing
- Immunization with live vaccine within 8 weeks of dosing
- Has a contraindication or inability to comply with antithrombotic prophylaxis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
- Genentech, Inc.collaborator
- Celgene Corporationcollaborator
Study Sites (22)
City of Hope /ID# 212211
Duarte, California, 91010, United States
Marin Cancer Care /ID# 208476
Greenbrae, California, 94904, United States
University of California, Los Angeles /ID# 208516
Los Angeles, California, 90095, United States
Karmanos Cancer Institute /ID# 208805
Detroit, Michigan, 48201, United States
Henry Ford Hospital /ID# 208481
Detroit, Michigan, 48202, United States
Duke University Hospital /ID# 208306
Durham, North Carolina, 27710, United States
UPMC Hillman Cancer Ctr /ID# 208121
Pittsburgh, Pennsylvania, 15232, United States
Westmead Hospital /ID# 210267
Westmead, New South Wales, 2145, Australia
Flinders Centre for Innovation /ID# 210697
Bedford Park, South Australia, 5042, Australia
St. Vincents Hosp Melbourne /ID# 210266
Fitzroy, Victoria, 3065, Australia
Austin Hospital /ID# 210268
Heidelberg, Victoria, 3084, Australia
Monash Medical Centre /ID# 210269
Melbourne, Victoria, 3168, Australia
Tom Baker Cancer Centre /ID# 208549
Calgary, Alberta, T2N 4N2, Canada
Princess Margaret Cancer Centr /ID# 208923
Toronto, Ontario, M5G 2M9, Canada
Hopital Maisonneuver-Rosemont /ID# 208550
Montreal, Quebec, H1T 2M4, Canada
McGill Univ HC /ID# 208486
Montreal, Quebec, H3G 1A4, Canada
Clinica Universitar de Navarra - Pamplona /ID# 209883
Pamplona, Navarra, Comunidad, 31008, Spain
Hospital Clinic de Barcelona /ID# 209888
Barcelona, 08036, Spain
Hspital Universitario Gregorio Maranon /ID# 209926
Madrid, 28009, Spain
Clinica Universitar de Navarra - Madrid /ID# 210131
Madrid, 28021, Spain
Hosp Univ 12 de Octubre /ID# 209887
Madrid, 28041, Spain
Hospital Univ Dr. Peset /ID# 209884
Valencia, 46017, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
December 20, 2018
First Posted
December 24, 2018
Study Start
April 29, 2019
Primary Completion
August 22, 2019
Study Completion
August 22, 2019
Last Updated
August 28, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.