Overview

A Study of Venetoclax and ABBV-838 Combination Therapy With Dexamethasone in Participants With Multiple Myeloma Whose Cancer Has Come Back or Had No Response to Recent Cancer Treatment

Status:
Withdrawn
Trial end date:
2021-04-28
Target enrollment:
0
Participant gender:
All
Summary
This is an open-label, multicenter clinical trial designed to evaluate the safety and potential efficacy of venetoclax and ABBV-838 combination therapy with dexamethasone in participants with relapsed or refractory multiple myeloma (MM) who have received 2 or more prior lines of therapy for multiple myeloma (MM). The study will consist of 2 arms: Arm A and Arm B (if applicable). Each arm will have a dose escalation and dose expansion portion.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Venetoclax
Criteria
Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
for participants in the dose escalation portion of the study and ECOG less than or
equal to 2 in the dose expansion portion.

- Received at least 2 prior therapies including an Immunomodulatory Thalidomide
Derivative Compounds (IMiD) and a proteasome inhibitor.

- Documented relapsed or progressive multiple myeloma on or after any regimen or is
refractory to the most recent line of therapy.

- Received at least 2 prior therapies including an IMiD and a proteasome inhibitor.

- Documented relapsed or progressive multiple myeloma on or after any regimen or is
refractory to the most recent line of therapy.

- Eligible for and agree to bone marrow (BM) aspirate prior to treatment start and at
designated times per protocol.

- Measurable disease at Screening, defined as at least one of the following M component
in serum (greater than or equal to 0.5 g/dL) and/or urine (greater than or equal to
0.2 g excreted in a 24 hour collection sample) or serum free light chain greater than
or equal to 100 mg/dL with an abnormal κ/λ ratio of less than 0.26 or greater than
1.65.

Exclusion Criteria:

- Received any anti-myeloma therapy (other than monoclonal antibodies), including
chemotherapy, radiotherapy, biological, immunotherapy or an investigational therapy,
including targeted small molecule agents within 5 half-lives (or 14 days if half-live
unknown) prior to first dose of first dose of venetoclax, ABBV-838, and dexamethasone.

- Received anti-myeloma monoclonal antibodies within 6 weeks prior to first dose of
venetoclax, ABBV-838, and dexamethasone.

- Has a significant history of renal, neurologic (peripheral neuropathy), psychiatric,
endocrinologic (diabetes mellitus), metabolic, immunologic, cardiovascular, pulmonary
or hepatic disease within the last 6 months.

- Received corticosteroid therapy at a dose equivalent to greater than or equal to 4
mg/day of dexamethasone within 3 weeks prior to first dose.