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

Study Overview
=================
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.

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.

Conditions
-----------------
Neoplasms, Thrombocytopenia, Multiple Myeloma, Lymphoma, Malignant

Intervention / Treatment
-----------------
* Drug: (PN-152,243)/PN-196,444


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: (PN-152,243)/PN-196,444|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |