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CompletedNCT00044018Updated Nov 12, 2019

CDC-501 Therapy in Relapsed or Refractory Multiple Myeloma

A Phase 2 interventional study of CDC-501 in Multiple Myeloma, sponsored by Celgene. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-12.

Sponsored by Celgene · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2002, registered Aug 2002).
Phase
Phase 2
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Multiple Myeloma

Keywords

  • Revimid
  • CC5013
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 102 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
102 participants (actual)

Interventions

  • DrugCDC-501
06

What researchers measure

Primary outcomes

  1. Confirmed M-Protein Response During Single Agent CDC-501 Therapy

    M-Protein response evaluated every 4 weeks through urine and serum electrophoresis.

    Time frame: Response assessed every 4 weeks; up to 62 months

07

Study locations

4 sites
  • H Lee Moffit Cancer Center
    Tampa, Florida 33612, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
  • Mayo Clinic
    Rochester, Minnesota 55902, United States
  • St Vincent's Cancer Center
    New York, New York 10011, United States
08

References and documents

Publications

  • 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. doi: 10.1182/blood-2006-04-015909. Epub 2006 Jul 13. PubMed 16840727 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00044018
Lead sponsor
Celgene
Responsible party
Sponsor
First posted
Aug 20, 2002
Start date
Apr 1, 2002
Primary completion
Dec 1, 2004
Completion
Feb 15, 2007
Last update
Nov 12, 2019

Study contacts

Robert Knight, MD
study director · Celgene Corporation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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