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NCT00037791 Clinical Trial

Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia

Multiple Myeloma Clinical Trial

Official title:
Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia in Patients Receiving Myelosuppressive Treatment Regimens Requiring Platelet Transfusion Support.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00037791
Other study ID # 98-OTPO-005
Secondary ID
Status Completed
Phase Phase 3
First received May 21, 2002
Last updated November 8, 2006
Start date December 1999
Est. completion date September 2002

Study information
Verified date September 2006
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Intensive chemotherapy is associated with significant thrombocytopenia, often requiring platelet transfusion to maintain platelet counts. This investigational drug has demonstrated the ability to increase platelet counts. This study will test the safety and efficacy of this investigational drug in the prevention of thrombocytopenia in patients with solid tumors, lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring platelet transfusion support.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date September 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients must have solid tumors, lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring platelet transfusion support

Exclusion Criteria:

- Patients must not have active bleeding (exclusions do apply) or history of platelet disorder

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• (PN-152,243)/PN-196,444

Locations
Country Name City State
Argentina Pfizer Investigational Site Buenos Aires Capital Federal
Argentina Pfizer Investigational Site Buenos Aires Capital Federal
Mexico Pfizer Investigational Site Mexico City DF
United States Pfizer Investigational Site Berkeley California
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site La Jolla California
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site New Orleans Louisiana

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the effectiveness of two schedules of intravenous rhTPO versus placebo as secondary prophylaxis in reducing the proportion of patients requiring platelet transfusion for severe chemotherapy-induced thrombocytopenia.
Secondary Identify the effect of rhTPO on the number of episodes of severe chemotherapy-induced thrombocytopenia(platelet count <15,000/mm3) and the number of platelet transfusions
Secondary Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO Prophylaxis
Secondary Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia
Secondary Assess the likelihood that patients will have adequate hematologic recovery to allow on-time chemotherapy administration in the subsequent cycle
Secondary Assess the safety of multiple intravenous doses of rhTPO
Secondary Determine the occurrence and clinical implications of any anti-rhTPO antibodies
Secondary Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness
Secondary Evaluate the impact of rhTPO administration on patient quality of life
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