Lymphoma, Malignant, Multiple Myeloma, Neoplasms, Thrombocytopenia
Conditions
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.
Interventions
DRUG(PN-152,243)/PN-196,444
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 | — |
| 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 | — |
| 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 | — |
| Assess the safety of multiple intravenous doses of rhTPO | — |
Countries
Argentina, Mexico, United States
Outcome results
None listed