Clinical Trial: Carfilzomib and Stem Cell Transplant for Plasma Cell Myeloma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase I / II Study Of Carfilzomib (CFZ) Intensification Early After Autologous Transplantation (AHCT) For Plasma Cell Myeloma

Brief Summary:

Background:

- Plasma cell myeloma is a type of cancer that affects the plasma cells in the bone marrow. It can be difficult to treat with chemotherapy. One possible treatment combines chemotherapy with a stem cell transplant. To make this treatment more effective, researchers want to give another drug along with the transplant. This drug, carfilzomib, is often used to help treat plasma cell myeloma. However, it is not usually given along with the transplant. Researchers want to see if it is safe and effective to combine the stem cell transplant with carfilzomib, and if it improves the results of the transplant.

Objectives:

- To test the safety and effectiveness of carfilzomib given with stem cell transplant for plasma cell myeloma.

Eligibility:

- Individuals between 18 and 75 years of age who are having a stem cell transplant to treat plasma cell myeloma.

Design:

  • Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies and a bone marrow biopsy will also be performed.
  • Participants will have their own stem cells collected for the transplant. The transplant will be performed according to the standard of care.
  • All participants will receive carfilzomib on the first 2 days after transplant. The study doctors will determine the number of additional doses that they may have.
  • Treatment will be monitored with frequent blood tests and imaging studies.

Detailed Summary:

Background:

  • Despite very significant progress in therapy for plasma cell myeloma (PCM) in the last decade, the disease remains mostly incurable.
  • High-dose chemotherapy followed by autologous hematopoietic cell transplantation (AHCT) continues to be a critical component of early treatment for PCM, but it is clear that the disease is not eradicated by the present high-dose therapy strategy, while intensifying the preparative regimen has, to this day, resulted in either no improvement in disease control or increased toxicity.
  • Carfilzomib (CFZ) is a newer proteasome inhibitor with increased activity and a safer toxicity profile than bortezomib in PCM. The favorable toxicity profile makes it a likely candidate for increasing anti-PCM drug exposure in the early post-AHCT period.

Objectives:

Primary Objectives

-Evaluate feasibility and toxicity of an increasing number of doses of CFZ administered in the early period post-AHCT for PCM

Secondary Objective

  • Evaluate the immune reconstitution post-AHCT following CFZ therapy
  • Evaluate the effects of the addition of CFZ in the early post-AHCT period on the response rate at day 100 post-AHCT

Eligibility:

  • Newly diagnosed subjects with PCM following induction therapy
  • Subjects with documentation of persistent/refractory disease who have received no mor
    Sponsor: National Cancer Institute (NCI)

    Current Primary Outcome:

    • Engraftment Failure Transplant Related Mortality [ Time Frame: up to day 100 ]
      Engraftment failure is defined as the failure to achieve neutrophil engraftment by day 21; defined from day 0, day of autologous hematopoietic cell transplantation (AHCT), as the first of three consecutive days on which the patient's absolute neutrophil count is greater than 0.5x10(9)/l following the nadir. Transplant related mortality is defined as any subject who dies in the first 100 days post-AHCT of any non-relapse related cause.
    • Number of Participants With Adverse Events [ Time Frame: 8 months and 15 days ]
      Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.


    Original Primary Outcome: Engraftment Failure Transplant Related Mortality

    Current Secondary Outcome:

    • Evaluate the Immune Reconstitution Post-Pre-autologous Hematopoietic Cell Transplantation (AHCT) Following Carfilzomib (CFZ) Therapy [ Time Frame: Post-AHCT following CFZ therapy ]
    • Evaluate the Effects of the Addition of Carfilzomib (CFZ) in the Early Post-Pre-autologous Hematopoietic Cell Transplantation (AHCT) Period on the Response Rate at Day 100 Post-AHCT [ Time Frame: Day 100 post-AHCT ]


    Original Secondary Outcome: Response rate at day 100 post-AHCT

    Information By: National Institutes of Health Clinical Center (CC)

    Dates:
    Date Received: August 3, 2012
    Date Started: July 2012
    Date Completion:
    Last Updated: May 2, 2016
    Last Verified: April 2016