Carfilzomib and Stem Cell Transplant for Plasma Cell Myeloma

Stopped early · Phase 1/Phase 2

Conditions studied: Multiple Myeloma, Leukemia, Plasma Cell

In brief

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.

Key facts

Study ID

NCT01658904

Run by

National Cancer Institute (NCI)

People needed

3

Starts

2012-07-01

Expected to finish

2014-04-01

Last updated by the study team

2016-06-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Prior allogeneic or autologous stem cell transplantation
• Prior treatment with Carfilzomib (CFZ) is not an exclusion
• History of recent (< 6 months) cerebrovascular accident
• History of documented recent (< 6 months) pulmonary embolus
• Clinically significant cardiac pathology:
• Myocardial infarction within 6 months prior to enrollment,
• Class III or IV heart failure according to New York Heart Association (NYHA),
• Uncontrolled angina,
• Severe uncontrolled ventricular arrhythmias, or
• Electrocardiographic evidence of acute ischemia or active conduction abnormalities felt to pose a significant cardiac riks by a Cardiology consultant
• Patients with a history of coronary artery bypass grafting or angioplasty will receive a cardiology evaluation and be considered on a case-by-case basis.
• Human immunodeficiency virus (HIV) seropositive
• Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to enrollment
• Active hepatitis B or C infection
• Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment
• Major surgery within 21 days prior to enrollment
• Non-hematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
• Significant neuropathy (Grades 3 4, or Grade 2 with pain) within 14 days prior to randomization
• Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize CFZ)
• Patients known or found to be pregnant
• Female patients of childbearing age who are unwilling to practice contraception
• Patients may be excluded at the discretion of the principal investigator (PI) if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk.
• Patients must be able to give informed consent

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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