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

Pfizer180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

180

Conditions

Neoplasms Thrombocytopenia Multiple Myeloma Lymphoma, Malignant

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Pfizer Investigational Site

Berkeley, California, 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, United States

Pfizer Investigational Site

Houston, Texas, United States

Pfizer Investigational Site

Buenos Aires, Buenos Aires F.D., Argentina

Pfizer Investigational Site

Buenos Aires, Buenos Aires F.D., Argentina

Pfizer Investigational Site

Mexico City, Mexico City, Mexico

Outcomes

Primary Outcomes

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 Outcomes

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

Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO Prophylaxis

Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia

Assess the likelihood that patients will have adequate hematologic recovery to allow on-time chemotherapy administration in the subsequent cycle

Assess the safety of multiple intravenous doses of rhTPO

Determine the occurrence and clinical implications of any anti-rhTPO antibodies

Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness

Evaluate the impact of rhTPO administration on patient quality of life