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Closed (no longer recruiting)Last updated: 31 January 2024

INTREPID-1: This phase I trial is evaluating two different types of an oral drug (oprozomib) in combination with dexamethasone (a steroid) and pomalidomide for the treatment of multiple myelomaA Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Oprozomib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Clinical summary

Summary

A multicenter, non-randomized, open-label, dose-exploration study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma. The study will be conducted in two parts. Part 1 will evaluate the formulations of oprozomib in combination with dexamethasone only. Part 2 will evaluate the formulations of oprozomib administered at increasing dose levels (dose escalation) in combination with pomalidomide and dexamethasone.

Conditions

This trial is treating patients with Multiple Myeloma.

Cancer

Blood Cancers Haematological

Age

People18 - 100

Phase

I

Trial Acronym

INTREPID-1

More information

Trial Identifiers

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Trial sponsor

AMGEN

Scientific Title

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Oprozomib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

Eligibility

Inclusion

  • Subject must have a pathologically documented, definitively diagnosed, multiple myeloma relapsed, or refractory progressive disease after at least 2 lines of therapy for multiple myeloma. Prior therapeutic treatment or regimens must include a proteasome inhibitor and lenalidomide.
  • Subject must be willing and able to undergo bone marrow aspirate per protocol (with or without bone marrow biopsy per institutional guidelines).
  • Measurable disease (assessed within 28 days prior to day 1)
  • Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.
  • Other Inclusion Criteria May Apply

Exclusion

  • Currently receiving treatment in another investigational device or drug study, or less than 28 days or 5 half-lives whichever is shorter since ending treatment on another investigational device or drug study(s).
  • Previously received an allogeneic stem cell transplant and the occurrence of one or more of the following: received the transplant within 6 months prior to study day 1;received immunosuppressive therapy within the last 3 months prior to study day 1;having signs or symptoms of acute or chronic graft-versus-host disease.
  • Autologous stem cell transplant < 90 days prior to study day 1.
  • Multiple myeloma with IgM subtype.
  • POEMs syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
  • Plasma cell leukemia (> 2.0 X109/L circulating plasma cells by standard differential).
  • Waldenstrom's macroglobulinemia.
  • Other Exclusion Criteria May Apply

Inclusion

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

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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