Status:
TERMINATED
Study Evaluating AMG 424 in Subjects With Multiple Myeloma
Lead Sponsor:
Xencor, Inc.
Conditions:
Relapsed/ Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A multi-center Phase 1, First-in-Human study conducted in 2 Parts, testing AMG 424 in subjects with relapsed/ refractory multiple myeloma.
Detailed Description
Part 1 of the study is dose evaluating and aimed at assessing the safety and tolerability of AMG 424 while determining the maximum tolerated dose (MTD) and/or biologically active dose in subjects with...
Eligibility Criteria
Inclusion
- Multiple myeloma meeting the following criteria:
- Pathologically-documented diagnosis of multiple myeloma that has relapsed after at least two prior lines of therapy that must include a proteasome inhibitor (PI), immunomodulatory drug (IMiD), and, where approved and available, anti-CD38 therapy in any order OR that is refractory to PI, IMiD, and anti-CD38 therapy.
- ◾Subjects who could not tolerate a PI, IMiDs, or a CD38-directed therapeutic antibody due to unacceptable toxicities are eligible to enroll in the study.
- Measurable disease as per IMWG response criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
Exclusion
- Known central nervous system involvement by multiple myeloma
- Previously received allogeneic stem cell transplant and one or more of the following:
- received the transplant \< 6 months prior to study Day 1
- received immunosuppressive therapy \< 3 months prior to study Day 1
- any active acute graft versus host disease (GvHD), grade 2- 4, according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment
- any systemic therapy against GvHD \< 2 weeks prior to study Day 1
- Autologous stem cell transplantation less than 90 days prior to study day 1
- Multiple myeloma with IgM subtype
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Evidence of primary or secondary plasma cell leukemia at the time of screening
- Waldenstrom's macroglobulinemia
- Amyloidosis
- Dexamethasone at cumulative doses of greater than 160 mg or equivalent \<3 weeks prior to study Day 1 is not allowed. Use of topical or inhaled steroids is acceptable
- Anticancer treatment (chemotherapy, IMiD, PI, molecular targeted therapy) \< 2 weeks prior to study Day 1
- Treatment with a therapeutic antibody targeting CD38 \< 12 weeks prior to study Day 1
- Systemic radiation therapy or major surgery \< 28 days prior to study Day 1 as well as focal radiotherapy \< 14 days prior to study Day 1.
- Major surgery within 28 days prior to study Day 1
Key Trial Info
Start Date :
July 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2020
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03445663
Start Date
July 31 2018
End Date
June 19 2020
Last Update
March 7 2023
Active Locations (8)
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1
Research Site
San Francisco, California, United States, 94143
2
Research Site
Charlotte, North Carolina, United States, 28204
3
Research Site
Winston-Salem, North Carolina, United States, 27157
4
Research Site
Cleveland, Ohio, United States, 44195