Vorinostat (MK0683, SAHA) + Revlimid + Dexamethasone in Multiple Myeloma
Information source: Merck
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Relapsed or Refractory Multiple Myeloma
Intervention: vorinostat (Drug); Comparator: lenalidomide (Drug); Comparator: Dexamethasone (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
This is a Phase I study of vorinostat in combination with lenalidomide and dexamethasone in
the patients with relapsed or refractory multiple myeloma. Patients will receive up to 8
cycles treatment with 28-day in each cycle. The safety and tolerability of the combination
regimen will be evaluated in this study.
Clinical Details
Official title: A Phase I Study of Vorinostat in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Maximum Tolerated Dose (MTD) for the combination regimen
Secondary outcome: Safety and tolerability; establish RP2D
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient is a male or female at lease 18 years old
- Patient has relapsed or refractory MM and has at least one prior therapy
- Female patients of childbearing potential must have 2 negative serum pregnancy tests
prior to receiving the first dose of study drugs
- Female patients who can become pregnant must agree to use 2 separate forms of
effective birth control at the same time, 4 weeks before, while taking, and for 4
weeks after stopping lenalidomide. Post menopausal patients should be free from menses
for > 2 years, or are surgically sterilized
- Male patient agrees to use an adequate method of contraception for the duration of the
study, even if the patient has undergone a successful vasectomy. Male patients must
agree to use a latex condom during sexual contact with a pregnant female or a female
who can become pregnant. This is required for the duration of the study, and for 4
weeks after stopping therapy
- Patient has at least 3 weeks washout prior to treatment
- Patient is able to swallow capsules and is able to take or tolerate oral medications
on a continuous basis
Exclusion Criteria:
- Patient has prior treatment with an HDAC inhibitor
- Patient has prior allogenetic bone marrow transplant
- Patient has received intravenous antibiotics, antiviral, or antifungal agents within 2
weeks prior to the start of the study drug
- Patient uses illicit drugs, substance abuse or had a recent history (within the last
year) of drug or alcohol abuse.
- Patient is pregnant or breast feeding or expecting to have baby during the course of
the study.
- Patient has HIV infection
- Patient has Hepatitis B/C infection
- Patient is currently receiving treatment for another type of cancer other than skin or
cervix cancer that has not been in remission for 5 years or longer
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Laboratoires Merck Sharp & Dohme - Chibret, Paris Cedex 8 75114, France; Recruiting
Jean-Marie Goehrs, Phone: 33-1-4754-89-90
Call for Information, Boston, Massachusetts 02115, United States; Recruiting
Call for Information, Hackensack, New Jersey 07601, United States; Recruiting
Call for Information, Houston, Texas 77030-0000, United States; Recruiting
Additional Information
(MedWatch - FDA maintained medical product safety Information) (PhRMA Clinical Study Results Database - web-based repository for clinical study results) (Merck: Patient & Caregiver U.S. Product Web Site)
Starting date: February 2008
Last updated: January 8, 2009
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