Study on Combination Therapy with Venetoclax, Daratumumab, and Dexamethasone (With and Without Bortezomib) for Patients with Relapsed or Hard-to-Treat Multiple Myeloma
Sponsor: AbbVie
ClinicalTrials ID:NCT03314181
This clinical trial is testing a combination of medications, including venetoclax, daratumumab, and dexamethasone, with or without bortezomib, to see if they are safe and effective for patients with multiple myeloma that has returned or is not responding to treatment.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to evaluate the safety and effectiveness of combining venetoclax, daratumumab, and dexamethasone, with or without bortezomib, in patients with multiple myeloma that has come back or is difficult to treat. The study has three parts: Part 1 involves patients with a specific genetic marker (t(11;14)) receiving venetoclax, daratumumab, and dexamethasone. Part 2 involves patients receiving venetoclax, daratumumab, bortezomib, and dexamethasone. Part 3 involves patients with the genetic marker receiving either the combination from Part 1 or Part 2. Parts 1 and 2 will start with increasing doses of venetoclax to find the best dose, followed by an expansion phase. Part 3 will compare the two combinations to see which works better.
Eligibility Criteria
Inclusion Criteria
- Must have a performance status score of 2 or less, meaning you are able to carry out all self-care but unable to carry out any work activities.
- Have multiple myeloma that has returned or not responded to previous treatments, as confirmed by specific medical criteria.
- Have measurable disease based on specific lab tests.
- Have received previous treatment for multiple myeloma.
- Must have bone marrow samples collected.
- For Parts 1 and 3, must have a specific genetic marker (t(11;14)).
- Must have adequate blood, kidney, and liver function.
Exclusion Criteria
- Have previously been treated with venetoclax or similar medications.
- For Parts 1 and 2: Have previously been treated with daratumumab or similar medications. For Part 3: Have had certain negative responses to daratumumab or similar medications.
- For Parts 2 and 3: Have not responded to or recently been treated with proteasome inhibitors.
- Have received certain treatments for multiple myeloma within a specific time before starting the study.
- Have known involvement of multiple myeloma in the central nervous system.
- Have significant medical conditions as specified in the study.
- Have had other active cancers within the past 3 years, with some exceptions.
- Have an active COVID-19 infection.
- Have allergies to any components of the study medications.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Univ of Colorado Cancer Center /ID# 167331 | 80045 | Aurora | Colorado |
| Moffitt Cancer Center /ID# 169614 | 33612-9416 | Tampa | Florida |
| Winship Cancer Institute of Emory University /ID# 165427 | 30322 | Atlanta | Georgia |
| The University of Chicago Medical Center /ID# 165429 | 60637-1443 | Chicago | Illinois |
| Beth Israel Deaconess Medical Center /ID# 210904 | 02215-5400 | Boston | Massachusetts |
| Dana-Farber Cancer Institute /ID# 166886 | 02215 | Boston | Massachusetts |
| Hackensack Univ Med Ctr /ID# 225111 | 07601 | Hackensack | New Jersey |
| Duplicate_Roswell Park Comprehensive Cancer Center /ID# 169615 | 14263 | Buffalo | New York |
| Weill Cornell Medicine/NYP /ID# 167605 | 10021-4872 | New York | New York |
| Atrium Health Carolinas Medical Center /ID# 164948 | 28203 | Charlotte | North Carolina |
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