Multiple Myeloma Clinical Trial

Study Evaluating AMG 424 in Subjects With Multiple Myeloma

Summary

A multi-center Phase 1, First-in-Human study conducted in 2 Parts, testing AMG 424 in subjects with relapsed/ refractory multiple myeloma.

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Full 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 relapsed/ refractory multiple myeloma.

Part 2 of the study will further evaluate safety and tolerability of the AMG 424 MTD dose determined in Part 1, in groups of subjects with relapsed/ refractory multiple myeloma that include those with high or low cytogenetic risk.

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Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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 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

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

27

Study ID:

NCT03445663

Recruitment Status:

Terminated

Sponsor:

Amgen

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There are 8 Locations for this study

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Research Site
San Francisco California, 94143, United States
Research Site
Charlotte North Carolina, 28204, United States
Research Site
Winston-Salem North Carolina, 27157, United States
Research Site
Cleveland Ohio, 44195, United States
Research Site
Seattle Washington, 98104, United States
Research Site
Milwaukee Wisconsin, 53226, United States
Research Site
Camperdown New South Wales, 2050, Australia
Research Site
Fitzroy, VIC Victoria, 3065, Australia

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

27

Study ID:

NCT03445663

Recruitment Status:

Terminated

Sponsor:


Amgen

How clear is this clinincal trial information?

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