CDC-501 Therapy in Relapsed or Refractory Multiple Myeloma

NCT ID: NCT00044018

Last Updated: 2019-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-01

Study Completion Date

2007-02-15

Brief Summary

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

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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CDC-501

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Knight, MD

Role: STUDY_DIRECTOR

Celgene Corporation

Locations

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H Lee Moffit Cancer Center

Tampa, Florida, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

St Vincent's Cancer Center

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16840727 (View on PubMed)

Other Identifiers

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CC-5013-MM-007

Identifier Type: -

Identifier Source: org_study_id

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