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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Lymphoma, Malignant; Multiple Myeloma; Thrombocytopenia; Neoplasms

Treatments: Drug: (PN-152,243)/PN-196,444

Study type: Interventional

Funder types: Industry

Identifiers

NCT00037791

98-OTPO-005

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind