Bortezomib and Vorinostat in Treating Patients With Multiple Myeloma Who Have Undergone Autologou… (NCT00839956) | Clinical Trial Compass
CompletedPhase 2
Bortezomib and Vorinostat in Treating Patients With Multiple Myeloma Who Have Undergone Autologous Stem Cell Transplant
United States31 participantsStarted 2009-02
Plain-language summary
This phase II trial studies the side effects of giving bortezomib together with vorinostat and to see how well it works in treating patients with multiple myeloma who have undergone autologous stem cell transplant. Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with vorinostat after an autologous stem cell transplant may stop the growth of any cancer cells that remain after transplant.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Any autologous patient who underwent high dose melphalan (\>= 140 mg/m\^2) therapy or peripheral blood stem cell (PBSC) rescue for any stage of multiple myeloma and did not participate in another clinical transplant trial whose primary endpoint is also evaluating long-term, disease-free survival, or survival
* Platelet count (transfusion independent) \> 75,000 cells/mm\^3 and absolute granulocyte count \> 1500 cells/mm\^3 for 5 calendar days after recovery from high dose therapy
* Consenting for study between 30 days to 120 days after transplant
* Female patient of childbearing potential has a negative serum pregnancy test beta-hCG within 72 hours prior to receiving the first dose of vorinostat
* Female patient is either post-menopausal, free from menses for \>= 2 years, surgically sterilized, or willing to use 2 adequate barrier methods of contraception to prevent pregnancy or agrees to abstain from heterosexual activity throughout the treatment on study, starting with visit 1 and for 3 months afterward
* Male patient agrees to use an adequate method of contraception for the duration of the treatment on study and for 3 months afterward
Exclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status \>= 2
* A left ventricular ejection fraction less than 45% pre-transplant
* Congestive heart disease with transplant, history of myocardial infarction (MI), history of coronary artery disease, or prolonged corrected QT interval (QTC)
* T…
What they're measuring
1
Toxicity as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0