Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatment vorinostat, lenalinomide and dexamethasone
Phase phase 1/phase 2
Sponsor Hackensack University Medical Center
Collaborator Merck Sharp & Dohme Corp.
Start date December 2011
End date December 2015
Trial size 92 participants
Trial identifier NCT01502085, PRO-2580

Summary

Phase IIb clinical trial to determine if resistance to a lenalidomide containing regimen can be overcome by the addition of vorinostat, in patients with relapsed and refractory multiple myeloma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Vorinostat: 400 mg po days 1-7 and 15-21 Lenalidomide: 25 mg po days 1-21 * Lenalidomide dose for patients with renal impairment (CrCL<50ml/min) has be dose adjusted according to package insert Dexamethasone: 40mg po days 1, 8, 15 and 22 for patients aged less than 75 years, 20mg for those aged 75 years and above
vorinostat, lenalinomide and dexamethasone
Vorinostat: 400 mg po days 1-7 and 15-21 Lenalidomide: 25 mg po days 1-21 * Lenalidomide dose for patients with renal impairment (CrCL<50ml/min) has be dose adjusted according to package insert Dexamethasone: 40mg po days 1, 8, 15 and 22 for patients aged less than 75 years, 20mg for those aged 75 years and above

Primary Outcomes

Measure
Assess the overall response rate (PR or better) of vorinostat in combination with lenalidomide and dexamethasone in patients with relapsed/refractory MM refractory to a previous lenalidomide containing regimen.
time frame: within 60 days after last dose of lenalinomide containing regimen or until progression on therapy

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Subjects must meet all of the following inclusion criteria to be eligible to enroll in this study: - International Staging System symptomatic multiple myeloma, as recently defined (Kyle et al., 2009) or Durie-Salmon stage I-III multiple myeloma, after at least one (1) prior anti-myeloma regimen. - Refractory to lenalidomide (administered either with dexamethasone or in combination with other agents); refractory will be defined as no response (

Additional Information

Official title A Phase IIb Trial of Vorinostat in Combination With Lenalidomide and Dexamethasone in Multiple Myeloma Patients Refractory to Previous Lenalidomide Containing Regimens
Principal investigator David Siegel, M.D., Ph.D
Description lenalidomide has been investigated in combination with both lenalidomide and bortezomib regimens. "Investigational" means that the drug is still being studied and that the study doctors are trying to find out more about it; such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating relapsed and/or refractory multiple myeloma. Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental because the FDA has not approved this combination. Your will receive 25mg of lenalidomide on days 1-21 every 28 days. Vorinostat is a drug that interferes with the life sustaining functions of the tumor cells. It has already received regulatory approval by the U.S. Food and Drug Administration (FDA) for the treatment of T-cell non-Hodgkin's Lymphoma in the United States. The usage of vorinostat in Multiple Myeloma is experimental (investigational) and has not been approved by the FDA, but studies in combination with proteasome inhibitors (bortezomib) and immunomodulatory (lenalidomide) agents are ongoing. You will receive either 400mg of vorinostat on days 1-7 and 15-21 every 28 days. Dexamethasone is a steroid that is known to cause cell death in multiple myeloma. Dexamethasone is FDA approved for the treatment of multiple myeloma and many other disease states. You will receive either Dexamethasone 40mg for those less than 75 years of age or 20mg for those aged 75 years and above on days 1, 8, 15 and 22 every 28 days In this research study the investigators are looking to evaluate the safety and efficacy of vorinostat when combined with lenalidomide and dexamethasone in treating relapsed and/or refractory multiple myeloma, refractory to lenalidomide.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Hackensack University Medical Center.