A Phase I Study of Vorinostat in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Inclusion Criteria:
- Patient is a male or female at least 18 years old
- Patient has relapsed or refractory MM and has had 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 histone deacetylase (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 a baby during the course
of the study
- Patient has human immunodeficiency virus (HIV) infection
- Patient has Hepatitis B/C infection
- Patient is currently receiving treatment for another type of cancer other than skin
or cervical cancer that has not been in remission for 5 years or longer