Status:
TERMINATED
Safety and Tolerability of BION-1301 in Adults With Relapsed or Refractory Multiple Myeloma (MM)
Lead Sponsor:
Chinook Therapeutics, Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a Phase 1/2 study designed to evaluate the safety and tolerability of BION-1301 in adults with relapsed or refractory multiple myeloma whose disease has progressed after 3 or more prior system...
Detailed Description
An open-label, multi-center, dose-selection Phase 1/2 study (also referred to as ADU-CL-16) evaluating BION-1301, a humanized monoclonal antibody directed against APRIL for the treatment of relapsed o...
Eligibility Criteria
Inclusion
- Key
- Individuals eligible to participate in this study must meet the following key criteria and additional criteria as specified in the protocol:
- Male or female, aged ≥ 18 years
- Confirmed diagnosis of MM per IMWG criteria
- Measurable disease as defined by one or more of the following:
- Serum M-protein ≥ 0.5 g/dL
- Urine M-protein ≥ 200 mg/24 hours
- Serum Free Light Chain (FLC) assay: involved FLC level ≥ 10 mg/dL provided serum FLC ratio is abnormal
- In cases where SPEP is unreliable, serum quantitative immunoglobulin (qIgA) ≥ 750 mg/dL (0.75 g/dL) is acceptable
- Relapsed or refractory (Rajkumar, 2011) to 3 or more different prior lines of therapy for MM, including immunomodulatory drugs (IMiDs), proteasome inhibitors (PIs), chemotherapies, or monoclonal antibodies, and not a candidate for, or intolerant to established therapy known to provide clinical benefit.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1
- Adequate organ and marrow function at Screening, as defined by the study protocol.
- Key
Exclusion
- Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, Waldenstrom's macroglobulinemia, or IgM myeloma
- Active plasma cell leukemia (˃ 2.0 × 109/L circulating plasma cells by standard differential)
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Prior treatment directed to B-cell Activating Factor (BAFF; BLyS), B-cell Maturation Antigen (BCMA;TNFSF17) or Transmembrane Activator and CAML interactor (TACI; TNFSF13B), including antibodies or BCMA- or TACI-directed Chimeric Antigen Receptor (CAR)-T cell therapy
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2019
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03340883
Start Date
November 15 2017
End Date
July 9 2019
Last Update
April 1 2021
Active Locations (7)
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1
James R. Berenson, MD, Inc
West Hollywood, California, United States, 90069
2
Winship Cancer Institute/Emory University
Atlanta, Georgia, United States, 30322
3
Ohio State University Wexner Medical Center James Cancer Hospital
Columbus, Ohio, United States, 43210
4
UPMC (University of Pittsburgh Medical Center) Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232