Know Cancer

or
forgot password

A Phase I Study of Vorinostat in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Relapsed or Refractory Multiple Myeloma

Thank you

Trial Information

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) for the combination regimen

Outcome Time Frame:

From Cycle 1 Day 1 to approximately 8 months (8 cycles)

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

0683-074

NCT ID:

NCT00642954

Start Date:

February 2008

Completion Date:

September 2013

Related Keywords:

  • Relapsed or Refractory Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location