Vorinostat and Lenalidomide After Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00729118|
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : May 18, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Plasma Cell Neoplasm||Drug: lenalidomide Drug: vorinostat||Phase 1|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vorinostat (SAHA) and Lenalidomide After Autologous Transplant for Patients With Multiple Myeloma|
|Actual Study Start Date :||September 26, 2008|
|Actual Primary Completion Date :||December 26, 2019|
|Actual Study Completion Date :||May 4, 2020|
Experimental: Lenalidomide + Vorinostat
Maintenance post autologous transplant
combined with Vorinostat (SAHA) days 1-21 of a 28-day cycle until progression or clinically significant toxicity.
Vorinostat (SAHA) will be administered orally beginning at dose level 1 starting day +90 ±6 days after HSCT for days 1 and 15-21 of a 28-day cycle combined with lenalidomide days 1-21 of a 28-day cycle until progression or clinically significant toxicity.
- Safety of patients receiving SAHA and lenalidomide following autologous PBSCT [ Time Frame: up to 3 years ]Patients will be assessed for Adverse events using the NCI CTCAE version 4.0 criteria
- Duration of response [ Time Frame: up to 3 years ]The time from progression to death
- Time to progression (TTP) [ Time Frame: up to 3 years ]Patients will be assessed for TTP from the start of treatment until the date of progression.
- Progression-free survival (PFS) [ Time Frame: 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 [ Time Frame: 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.
- Duration of overall response [ Time Frame: 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 [ Time Frame: up to 3 years ]The survival time defined as the time from start of treatment to the date of death.
- Response rate [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729118
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Yvonne C. Efebera, MD||Ohio State University Comprehensive Cancer Center|