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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.

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Northwestern Medical Faculty Foundation
Chicago, Illinois, 60611 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Multiple Myeloma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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%).

NCT00555906
Pfizer
Completed
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.

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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.
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
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Multiple Myeloma
  • 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.
Experimental: 1
Interventions:
  • Drug: Bortezomib
  • Drug: Dexamethasone
  • Drug: PD 0332991
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
March 2013
August 2012   (Final data collection date for primary outcome measure)

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%).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Germany,   United States
 
 
NCT00555906
A5481004
2010-022515-20 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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