An Investigational Drug, Palbociclib (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.

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

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

Key facts

Study ID

NCT00555906

Run by

Pfizer

People needed

53

Starts

2008-01-01

Expected to finish

2013-03-01

Last updated by the study team

2015-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of symptomatic multiple myeloma as defined by International Myeloma Working Group (IMWGURC).
• Phase 1: Relapsed or relapsed/refractory myeloma after at least 1 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.

You may not qualify if…

• 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 level changes, e.g. very low platelets, while on previous bortezomib therapy
• Prior radiation therapy to > 25% of the bone marrow (whole pelvis is 25%).

Where it is running

• Northwestern Medical Faculty Foundation — Chicago, Illinois, United States
• Northwestern Memorial Hospital/Main Labs — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Kansas Cancer Center and Medical Pavilion — Westwood, Kansas, United States
• University of Maryland — Baltimore, Maryland, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Barnes-Jewish Hospital — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Nebraska Methodist Hospital — Omaha, Nebraska, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• New York Presbyterian, Weill Cornell Medical College — New York, New York, United States
• University of Pennsylvania Abramson Cancer Center — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Cancer Institute — Pittsburgh, Pennsylvania, United States
• Hollings Cancer Center — Charleston, South Carolina, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vseobecna fakultni nemocnice v Praze — Prague, Czechia
• Universitaetsklinikum Heidelberg — Heidelberg, Germany
• Klinikum Johannes-Gutenberg -Universitaet, III. Medizinische Klinik und Poliklinik — Mainz, Germany

Full record on ClinicalTrials.gov

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