CDC-501 Therapy in Relapsed or Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044018
• Other study ID #: CC-5013-MM-007
• Status: Completed
• Phase: Phase 2
• Start date: April 1, 2002
• Est. completion date: February 15, 2007

Study information

• Verified date: November 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: February 15, 2007
• Est. primary completion date: December 1, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• CDC-501

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	St Vincent's Cancer Center	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	H Lee Moffit Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

United States, 

References & Publications (1)

Richardson PG, Blood E, Mitsiades CS, Jagannath S, Zeldenrust SR, Alsina M, Schlossman RL, Rajkumar SV, Desikan KR, Hideshima T, Munshi NC, Kelly-Colson K, Doss D, McKenney ML, Gorelik S, Warren D, Freeman A, Rich R, Wu A, Olesnyckyj M, Wride K, Dalton WS, Zeldis J, Knight R, Weller E, Anderson KC. A randomized phase 2 study of lenalidomide therapy for patients with relapsed or relapsed and refractory multiple myeloma. Blood. 2006 Nov 15;108(10):3458-64. Epub 2006 Jul 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed M-Protein Response During Single Agent CDC-501 Therapy	M-Protein response evaluated every 4 weeks through urine and serum electrophoresis.	Response assessed every 4 weeks; up to 62 months