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A Study to Assess AMG 701 Montherapy, or in Combination With Pomalidomide, With or Without, Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Status
Completed
Cancer Type
Multiple Myeloma
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03287908
Protocol IDs
20170122 (primary)
NCI-2017-02084
2017-001997-41
Study Sponsor
Amgen, Inc.

Summary

The primary purpose of the phase 1 part of the study is to evaluate safety and tolerability
of AMG 701 monotherapy to identify the RP2D for AMG 701 monotherapy followed by a
dose-confirmation part to gather further safety data for AMG 701 monotherapy at the RP2D in
adult subjects with relapsed/refractory multiple myeloma (RRMM). In addition, this study will
include a sequential dose exploration part to identify the RP2D of AMG 701 in combination
with pomalidomide, with and without dexamethasone (AMG 701-P+/-d). Phase 2 will consist of
the dose-expansion part to gain further efficacy and safety experience with AMG 701
monotherapy in adult subjects with RRMM.

Eligibility

  1. Multiple myeloma meeting the following criteria:
  2. Pathologically-documented diagnosis of multiple myeloma that is relapsed or is refractory as defined by the following:
  3. Relapsed after > or = 3 lines of prior therapy that must include all approved and available therapies deemed eligible by the investigator, inclusing at a minimum of a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and, where approved and available, a CD38-directed cytolytic antibody in combination in the same line or separate lines of treatment OR refractory to PI, IMiD, and CD38- directed cytolytic antibody,
  4. Subjects who could not tolerate a PI, IMiDs, or a CD38-directed cytolytic antibody are eligible to enroll in the study.
  5. Measurable disease as per IMWG response criteria
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status of = 2 Inclusion criteria specific to AMG 701-P±d include:
  7. Subjects must have received = 2 lines of prior therapy that must include a proteasome inhibitor (PI), lenalidomide, and where approved and available a CD38-directed antibody. These therapies may be in the same line or separate lines of treatment.
  8. Subjects must have responded to at least 1 prior line with at least a PR.
  9. Subjects that have previously received pomalidomide must not have been removed from therapy due to toxicity attributable to pomalidomide and must be at least 6 months from their last dose of pomalidomide.
  10. Subjects must not have known intolerance to doses of dexamethasone up to 40 mg weekly (20 mg weekly if > 75 years).

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.