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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.

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: November 8, 2007
Last updated: January 16, 2014
Last verified: January 2014

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.

Condition Intervention Phase
Multiple Myeloma
Drug: Bortezomib
Drug: Dexamethasone
Drug: PD 0332991
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1/2 Open-Label Study Of The Safety And Efficacy Of PD 0332991 In Combination With Bortezomib And Dexamethasone In Patients With Refractory Multiple Myeloma

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Phase 2 - determine the objective response rate of PD 0332991 in combination with bortezomib and dexamethasone [ Time Frame: 1.5 yr ] [ Designated as safety issue: No ]
  • Phase 1 - determine the maximum tolerated dose and recommended Phase 2 dose for PD 0332991 in combination with bortezomib and dexamethasone [ Time Frame: 2 yr ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Phase 1 - changes in the phosphorylation status of the Rb protein in myeloma cells [ Time Frame: 2 yr ] [ Designated as safety issue: No ]
  • Phase 2 - determine the time to progression, progression-free survival, duration of response and overall survival of PD 0332991 in combination with bortezomib and dexamethasone [ Time Frame: 1.5 yr ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: January 2008
Study Completion Date: March 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Bortezomib
Escalating doses of bortezomib will be administered intravenously on Days 8, 11, 15 and 18 of a 28-day cycle (Schedule A) or of a 21-day cycle (Schedule B). The planned doses to be evaluated are 0.7, 1 and 1.3 mg/m2 in combination with PD 0332991 and dexamethasone.
Other Name: Velcade
Drug: Dexamethasone
20 mg, orally on Days 8, 11, 15 and 18 of a 28 day cycle (Schedule A) or of a 21-day cycle (Schedule B) in combination with PD 0332991 and bortezomib.
Drug: PD 0332991
Escalating doses of PD 0332991 will be administered orally on Days 1-21 of a 28-day cycle for Schedule A and on Days 1-12 of a 21-day cycle for Schedule B. The planned doses to be evaluated are 50, 75, 100 mg and 125 mg once daily in combination with bortezomib and dexamethasone.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 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.

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 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%).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00555906

United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60611
United States, Kansas
Pfizer Investigational Site
Kansas City, Kansas, United States, 66160
Pfizer Investigational Site
Westwood, Kansas, United States, 66205
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21201
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110-1093
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68114
United States, New York
Pfizer Investigational Site
Buffalo, New York, United States, 14263
Pfizer Investigational Site
New York, New York, United States, 10021
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29425
Czech Republic
Pfizer Investigational Site
Praha 2, Czech Republic, 12808
Pfizer Investigational Site
Heidelberg, Germany, 69120
Pfizer Investigational Site
Mainz, Germany, 55131
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT00555906     History of Changes
Other Study ID Numbers: A5481004
Study First Received: November 8, 2007
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Vascular Diseases
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on March 03, 2015