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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

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


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%).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase 2 - determine the objective response rate of PD 0332991 in combination with bortezomib and dexamethasone

Outcome Time Frame:

1.5 yr

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A5481004

NCT ID:

NCT00555906

Start Date:

January 2008

Completion Date:

August 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteKansas City, Kansas  66112
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteEasley,, South Carolina  29640
Pfizer Investigational SiteOmaha, Nebraska  68198