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
NCT ID: NCT03785184
Last Updated: 2019-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2019-04-29
2019-08-22
Brief Summary
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This study will consist of 2 parts: Part 1 Dose Escalation and Part 2 Dose Expansion.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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).
venetoclax
tablet; oral
lenalidomide
capsule; oral
dexamethasone
tablet; oral
Interventions
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venetoclax
tablet; oral
lenalidomide
capsule; oral
dexamethasone
tablet; oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Celgene Corporation
INDUSTRY
AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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City of Hope /ID# 212211
Duarte, California, United States
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
Austin Hospital /ID# 210268
Heidelberg, Victoria, Australia
Monash Medical Centre /ID# 210269
Melbourne, Victoria, Australia
Tom Baker Cancer Centre /ID# 208549
Calgary, Alberta, Canada
Princess Margaret Cancer Centr /ID# 208923
Toronto, Ontario, Canada
Hopital Maisonneuver-Rosemont /ID# 208550
Montreal, Quebec, Canada
McGill Univ HC /ID# 208486
Montreal, Quebec, Canada
Clinica Universitar de Navarra - Pamplona /ID# 209883
Pamplona, Navarra, Comunidad, Spain
Hospital Clinic de Barcelona /ID# 209888
Barcelona, , Spain
Hspital Universitario Gregorio Maranon /ID# 209926
Madrid, , Spain
Clinica Universitar de Navarra - Madrid /ID# 210131
Madrid, , Spain
Hosp Univ 12 de Octubre /ID# 209887
Madrid, , Spain
Hospital Univ Dr. Peset /ID# 209884
Valencia, , Spain
Countries
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Related Links
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This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Other Identifiers
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M16-104
Identifier Type: -
Identifier Source: org_study_id
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