Vorinostat and Lenalidomide After Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma
- Conditions
- Multiple MyelomaPlasma Cell Neoplasm
- Interventions
- Registration Number
- NCT00729118
- Brief Summary
RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving vorinostat together with lenalidomide may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when given together with lenalidomide after autologous stem cell transplant in treating patients with multiple myeloma.
- Detailed Description
OBJECTIVES:
Primary
* To assess the dose-limiting toxicities and safety of vorinostat and lenalidomide after autologous peripheral blood stem cell transplantation in patients with multiple myeloma.
* To evaluate the overall response rate to the combination of Vorinostat (SAHA) and lenalidomide.
Secondary
* To evaluate the effect of this treatment regimen on natural killer cell activity and regulatory T cells in the post-transplant period.
* To determine preliminary clinical activity of this treatment regimen by assessing overall survival and progression-free survival of these patients.
* To obtain pilot data regarding an association between this treatment regimen and patient quality of life and circulating inflammatory cytokines.
OUTLINE: This is a dose-escalation study of vorinostat.
Patients receive oral vorinostat alone once daily on days 1-21 in course 1. For the second and subsequent courses, patients receive oral vorinostat in combination with oral lenalidomide once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection periodically for correlative laboratory studies. Studies include functional immune assays (T-cell and natural killer cell activity and regulatory T-cell recovery) by fluorescence activated cell sorting (FACS) or ELISPOT; analysis of inflammatory markers (cytokines and catecholamines); and analysis of global H3 and H4 acetylation by immunohistochemistry.
Quality of life is assessed periodically using the Brief Pain Inventory (Short Form), The Center for Epidemiologic Studies Depression Scale (CES-D-10), a 9-item Brief Fatigue Inventory, and the FACT-G questionnaires.
After completion of study treatment, patients are followed for at least 30 days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lenalidomide + Vorinostat vorinostat Maintenance post autologous transplant Lenalidomide + Vorinostat lenalidomide Maintenance post autologous transplant
- Primary Outcome Measures
Name Time Method Safety of patients receiving SAHA and lenalidomide following autologous PBSCT up to 3 years Patients will be assessed for Adverse events using the NCI CTCAE version 4.0 criteria
- Secondary Outcome Measures
Name Time Method Duration of response up to 3 years The time from progression to death
Time to progression (TTP) up to 3 years Patients will be assessed for TTP from the start of treatment until the date of progression.
Duration of overall response up to 3 years The duration computed for subjects whose best response is either PR or CR or SD and is measured when first met for complete or partial response(whichever comes first) until first date of progressive disease or death
Overall survival up to 3 years The survival time defined as the time from start of treatment to the date of death.
Response rate up to 3 years Tumor response defined as the total number of patients whose best response is PR or CR or SD, divided by the number of patients
Progression-free survival (PFS) up to 3 years PFS is the time from the first dose a patient receives until disease progression or death at trial closure.
Time to response up to 3 years From the first dose of study therapy until measurement criteria are first met progressive response (PR), complete response (CR) or stable disease (SD). The patients best response is recorded.
Trial Locations
- Locations (1)
Ohio State University
🇺🇸Columbus, Ohio, United States