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An Investigational Drug, PD 0332991, Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma.

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II, Phase I

Treatment

Active

18 and over

Pharmaceutical / Industry

A5481004
NCT00555906

Trial Description

Summary

This is a Phase 1/2 study evaluating the safety and anti-tumor activity of PD 0332991 in combination with Velcade and dexamethasone in patients who have received at least one previous treatment for multiple myeloma.

Eligibility Criteria

Inclusion Criteria:

Diagnosis of symptomatic multiple myeloma as defined by International Myeloma Working Group (IMWGURC).

Phase 1: Relapsed or relapsed/refractory myeloma after at least 2 previous treatments and with a life expectancy of more than 3 months. Phase 2: Measurable (as defined by IMWGURC) disease after at least 1 previous treatment.

Exclusion Criteria:

History of allogeneic stem cell transplant.

Phase 2 only: Prior bortezomib therapy will only be allowed if there was a demonstrated positive response, and disease progression occurred off therapy.

Must have not experienced significant blood changes, e.g. very low platelets, while on previous bortezomib therapy

Prior radiation therapy to > 25% of the bone marrow (whole pelvis is 25%).

Trial Contact Information

Trial Lead Organizations/Sponsors

Pfizer Incorporated

Pfizer CT.gov Call Center

Study Director

Pfizer Oncology Clinical Trial Information Service		Ph: 1-877-369-9753
		Email: PfizerCancerTrials@emergingmed.com

Pfizer CT.gov Call Center

Ph: 1-800-718-1021

Trial Sites

U.S.A.

New York

New York

Pfizer Investigational Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00555906
Information obtained from ClinicalTrials.gov on October 06, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.