Carfilzomib Treatment for Patients with Relapsed and Refractory Multiple Myeloma

Sponsor: Amgen

Expanded Access
Approved for Marketing
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT01410500

Provider View

This study offers access to the drug carfilzomib for patients with multiple myeloma that has returned or not responded to previous treatments, and who cannot join other carfilzomib trials.

Patient Parameters

Program Overview

The aim of this study is to provide the drug carfilzomib to patients with multiple myeloma that has come back or not responded to treatment. This is for patients who have already tried at least four different treatments and cannot join other carfilzomib studies.

Description

This study is open to patients with multiple myeloma that has returned or not responded to treatment. It allows them to receive carfilzomib, a drug that may help manage their condition. The study is open to patients who have already tried at least four different treatments and are not eligible for other carfilzomib studies. Participants will receive carfilzomib and be monitored for safety and effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with multiple myeloma.
  • Aged 18 years or older.
  • Able to perform daily activities with minimal assistance (ECOG status 0-2).
  • Expected to live at least 3 more months.
  • Have measurable disease, such as specific levels of M-protein in blood or urine.
  • Have tried at least four previous treatments, including specific types of drugs like immunomodulatory agents, bortezomib, alkylating agents, and corticosteroids.
  • Currently experiencing disease progression.
  • Have a heart function of at least 40%.
  • Have adequate liver function and blood cell counts.
  • Have a creatinine clearance of at least 15 mL/minute.
  • Women of childbearing potential must test negative for pregnancy and agree to use contraception. Men must use contraception if sexually active with women of childbearing potential.
  • Willing to provide written informed consent.

Exclusion Criteria

  • Have previously been treated with carfilzomib or are part of another Phase 3 carfilzomib trial.
  • Have HIV or active hepatitis A, B, or C.
  • Have an active infection requiring treatment.
  • Are using other cancer treatments, except for certain allowed medications.
  • Are pregnant or breastfeeding.
  • Have a history of plasma cell leukemia or amyloidosis.
  • Have severe heart problems or recent heart attack.
  • Cannot tolerate hydration due to existing health issues.
  • Have Waldenström macroglobulinemia or IgM myeloma.

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