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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 Site Detroit, Michigan  48201
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Kansas City, Kansas  66112
Pfizer Investigational Site Westminster, Maryland  21157
Pfizer Investigational Site Columbia, Missouri  65201
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Easley,, South Carolina  29640
Pfizer Investigational Site Omaha, Nebraska  68198