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Study Summary
No. 2005-0438:.......Myeloma......Donna M. Weber......Lymphoma/Myeloma
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Study Summary Title
Study Summary
Number:
2005-0438
Study Title:Phase I Clinical Trial of Oral Vorinostat (MK-0683) in Combination with Bortezomib in Patients with Advanced Multiple Myeloma
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Physician New Patient Referral
Name:Donna M. WeberPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Lymphoma/MyelomaReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2860
Contact us about clinical trials
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General Information
Disease Group:MyelomaSupported By:N/A
Phase of Study:Phase I/Phase IIReturn
Visit:
Patients will be assessed for safety weekly during the first cycle. Patients
will return for treatment on days 4, 8, 11 and 15 of each 21-day cycle for up
to 8 cycles.
Treatment
Agents:
Bortezomib
Dexamethasone
Vorinostat
Home Care:N/A
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to find the highest tolerated dose
of vorinostat that can be taken in combination with standard doses of
bortezomib (VelcadeŽ), in patients with advanced multiple myeloma. Researchers
will look at the safety and tolerability of this drug combination, as well as
how the cancer responds to this combination.
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Study Objectives / Outcomes
Primary:

To determine the maximum tolerated dose (MTD) for the combination of oral vorinostat and
standard doses of bortezomib in patients with advanced multiple myeloma.

Secondary:

To assess the safety and tolerability of this combination regimen of vorinostat and bortezomib.

Exploratory:

a. To estimate response rate, time to response, response duration and time to progression (TTP) for vorinostat and bortezomib when used in combination.
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Study Status Information
Study Activation / Registration Date:02/10/2006
IRB Review and Approval Date:08/03/2005
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:40
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Patient must have an established diagnosis of multiple myeloma based on standard criteria.

2) Patient must have relapsed and/or refractory multiple myeloma after the most recent treatment regimen as per EBMT criteria.

3) Patient must have quantifiable monoclonal M-protein in serum and/or urine.

4) Patient is at least 18 years of age.

5) Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

6) Patient has adequate bone marrow reserve with: a.) absolute neutrophil count (ANC) equal to or greater than 1000/microL; b.) platelet count equal to or greater than 75,000/microL.

7) Patient has adequate liver function with: a.) Total bilirubin within normal institutional limits; b.) ALT (SGPT) and AST(SGOT) less than or equal to 2.5 x institutional upper limit of normal (ULN).

8) Patient has adequate renal function with: a.) serum creatinine less than or equal to 1.5 x institutional ULN OR b.) measured 24 hour urine creatinine clearance greater than or equal to 60 mL/min.

9) Patient must have a life expectancy of greater than 3 months.

10) Patient must be able to swallow capsules.

11) Patient must be at least 3 weeks from prior chemotherapy, radiation therapy, biological therapy, steroid therapy (patients receiving steroids for indications other than treatment of myeloma may be exempted from this requirement by the Principal Investigator after discussion with the medical monitor, if the use of steroids consists of 10 mg or less prednisone per day), major surgery or other investigational anticancer therapy and have recovered from prior toxicities. Commercially available bisphosphonates are allowed for prophylaxis or treatment of myeloma bone disease.

12) Male patient agrees to use an adequate method of contraception for the duration of the study.

13) Female patient is either post menopausal, free from menses for > 2 years, surgically sterilized or willing to use 2 adequate barrier methods of contraception to prevent pregnancy or agrees to abstain from heterosexual activity throughout the study, starting with visit 1.

14) Female patients of childbearing potential must have a negative serum pregnancy test (BhCG) within 72 hours of receiving the first dose of vorinostat.

15) Patient has the ability to understand and willingness to sign the informed consent form.

16) Patients who are bortezomib naive are eligible as well as patients who have not received bortezomib in three months prior to enrollment.

Exclusion Criteria:1) Patient plans to undergo autologous or allogeneic bone marrow transplantation within 4 weeks of the initiation of vorinostat administration.

2) Patient had prior treatment with an HDAC inhibitor (e.g., Depsipeptide, MS-275, LAQ-824, PXD-101, valproic acid, etc.)

3) Patient with concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and antitumor activity of vorinostat.

4) Patient with clinically significant illness including, but not limited to the following: active systemic infection, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, or uncontrolled cardiac arrhythmia, renal failure or any other condition (including laboratory abnormalities) that in the opinion of the Investigator places the patient at unacceptable risk for adverse outcome if he/she were to participate in the study.

5) Patient with psychiatric illness/social situations that would limit compliance with study medication and requirements.

6) Patient is pregnant or lactating.

7) Patient with known human immunodeficiency virus (HIV) infection.

8) Patient with active hepatitis B and/or hepatitis C infection.

9) Patient with a "currently active" second malignancy, other than non-melanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled. Patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for more than 5 years and are considered by their physician to be at less than 30% risk of relapse.

10) Patient with non-secretory myeloma.

11) Patient with plasma cell leukemia defined as the presence of more than 20% plasma cells in the peripheral blood and an absolute plasma cell count of at least 2000 microL.

12) Patient with corrected serum calcium of greater than 11.5 mg/dL.

13) Patient with pre-existing neuropathy equal to or greater than Grade 2.

14) Patient with a history of allergic reaction attributable to compounds containing boron or mannitol.

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Links
Registration Number: NCT00111813
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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