CDC-501 Therapy in Relapsed or Refractory Multiple Myeloma

Sponsor

Celgene (Industry)

Overall Status

Completed

CT.gov ID

NCT00044018

Collaborator

(none)

102

Enrollment

Locations

58.5

Actual Duration (Months)

25.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to select the dose regimen of CDC-501 that provides the most promising evidence of efficacy.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: CDC-501	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label Study to Evaluate the Efficacy and Safety of Two CDC-501 Dose Regimens When Used Alone or in Combination With Dexamethasone for the Treatment Relapsed or Refractory Multiple Myeloma

Actual Study Start Date :

Apr 1, 2002

Actual Primary Completion Date :

Dec 1, 2004

Actual Study Completion Date :

Feb 15, 2007

Outcome Measures

Primary Outcome Measures

Confirmed M-Protein Response During Single Agent CDC-501 Therapy [Response assessed every 4 weeks; up to 62 months]
M-Protein response evaluated every 4 weeks through urine and serum electrophoresis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Subject must be diagnosed with multiple myeloma (with measurable M-Protein in serum and/or urine), and be considered to have disease progression after at least two cycles of treatment or have relapsed after treatment.
Subject must understand and voluntarily sign an informed consent document.
Subject must not have received corticosteroids, other chemotherapy, thalidomide, or other investigational agents, within 21 days of baseline
ECOG (Zubrod) performance status of 0 to 2.
Subject must be able to adhere to the study visit schedule and other protocol requirements.
Women of childbearing potential (WCBP ) must have a negative serum or urine pregnancy test within 7 days of baseline. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H Lee Moffit Cancer Center	Tampa	Florida	United States	33612
2	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
3	Mayo Clinic	Rochester	Minnesota	United States	55902
4	St Vincent's Cancer Center	New York	New York	United States	10011