Clinical trial NCT00037791: Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neoplasms
Thrombocytopenia
Multiple Myeloma
Lymphoma, Malignant
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2002-05-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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:
measure: 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
measure: Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO Prophylaxis
measure: Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia
measure: Assess the likelihood that patients will have adequate hematologic recovery to allow on-time chemotherapy administration in the subsequent cycle
measure: Assess the safety of multiple intravenous doses of rhTPO
measure: Determine the occurrence and clinical implications of any anti-rhTPO antibodies
measure: Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness
measure: Evaluate the impact of rhTPO administration on patient quality of life
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Pfizer Investigational Site
state: California
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
state: Capital Federal
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
state: Capital Federal
city: Mexico City
country: Mexico
facility: Pfizer Investigational Site
state: DF
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: