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Closed (no longer recruiting)Last updated: 7 February 2024

AMG 224: This phase I trial is evaluating the drug AMG 224 as a treatment for Multiple Myeloma in patients who have relapsedA Phase 1 First in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 224 in Subjects With Relapsed or Refractory Multiple Myeloma

Clinical summary

Summary

This is a first in human phase 1 multicenter open label study in subjects with relapsed or refractory multiple myeloma.

Conditions

This trial is treating patients with Multiple Myeloma.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

Trial Acronym

AMG 224

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

AMGEN

Scientific Title

A Phase 1 First in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 224 in Subjects With Relapsed or Refractory Multiple Myeloma

Eligibility

Inclusion

- Pathologically documented,multiple myeloma relapsed or refractory progressive disease after at least 3 lines of therapy for multiple myeloma.

Prior therapeutic treatment or regimens must include proteasome inhibitors (e.g. bortezomib) and immunomodulatory drugs (e.g. lenalidomide).

  • Willing and able to undergo bone marrow aspirate per protocol (with or without bone marrow biopsy per institutional guidelines).
  • Measurable disease per the International Myeloma Working Group (IMWG) response criteria
  • Hematological function, as follows, without transfusion support:
  • Absolute neutrophil count ≥ 1.0 X 10^9/L,
  • Platelet count ≥ 75 X 10^9/L (in patients with < 50% of bone marrow nucleated cells were plasma cells) or ≥ 50 X 10^9/L (in patients with ≥ 50% of bone marrow nucleated cells were plasma cells) without transfusion or growth factor support
  • Hemoglobin > 8 g/dL (> 80 g/L)
  • Adequate renal and hepatic function
  • Left ventricular ejection fraction (LVEF) > 50%

Exclusion

  • Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study
  • Autologous stem cell transplant less than 90 days prior to study day 1
  • Multiple myeloma with IgM subtype
  • POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) syndrome, Plasma cell leukemia, Waldenstrom's macroglobulinemia or Amyloidosis
  • Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 7 days prior to study day
  • Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II)
  • A baseline ECG QTcF > 470 msec
  • Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days prior to study day 1

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

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