Overview

A Study Evaluating ABT-199 in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy

Status:
Completed
Trial end date:
2019-07-16
Target enrollment:
0
Participant gender:
All
Summary
The primary objectives of this study are to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and the recommended phase two dose (RPTD) of ABT-199 when administered in subjects with relapsed /refactory multiple myeloma who are receiving bortezomib and dexamethasone as their standard therapy.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie
AbbVie (prior sponsor, Abbott)
Collaborator:
Genentech, Inc.
Treatments:
BB 1101
Bortezomib
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Venetoclax
Criteria
Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance score less than or equal to 1

- Diagnosis of multiple myeloma previously treated with at least 1 prior line of therapy
(dose escalation only) or (safety expansion only) received treatment with a proteasome
inhibitor or an IMiD(r) or immunomodulatory agent (e.g., thalidomide, lenalidomide).
Induction therapy and following stem cell transplant are considered a single line of
therapy.

- Measurable disease at Screening: Serum monoclonal protein greater than or equal to 1
g/dL by protein electrophoresis, or greater than or equal to 200 mg monoclonal protein
in the urine on 24-hr electrophoresis, or serum immunoglobulin free light chain
greater than or equal to 10 mg/dL and abnormal serum immunoglobulin kappa to lambda
free light chain ratio.

- Subjects with a history of autologous or allogenic stem cell transplant must have
adequate bone marrow independent of any growth factor support, and have recovered from
any transplant related toxicity(s); and either greater than 100 days post-autologous
transplant (prior to first dose of study drug) or greater than or equal to 6 months
post-allogenic transplant (prior to first dose of study drug) and not have active
graft-versus-host disease (i.e., requiring treatment).

- Subject must have adequate coagulation, renal, and hepatic function, per laboratory
reference range at Screening.

Exclusion Criteria:

- Exhibits evidence of other clinically significant uncontrolled condition(s),
including, but not limited to: uncontrolled systemic infection (viral, bacterial, or
fungal), diagnosis of fever and neutropenia within 1 week prior to first dose of study
drug

- Cardiovascular disability status of New York Heart Association Class greater than or
equal to 2. Class 2 is defined as cardiac disease in which patients are comfortable at
rest but ordinary physical activity results in fatigue, palpitations, dyspnea or
anginal pain.

- Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic,
immunologic, cardiovascular, pulmonary or hepatic disease, that in the opinion of the
investigator, would adversely affect his/her participation in the study.

- History of other active malignancies other than multiple myeloma within the past 3
years prior to study entry, with the following exceptions: adequately treated in situ
carcinoma of the cervix uteri, basal cell carcinoma of the skin or localized squamous
cell carcinoma of the skin, previous malignancy confined and surgically resected (or
treated with other modalities) with curative intent.

- Tested positive for HIV or hepatitis.