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The Prophylactic Use of Loratadine for Granulocyte-Colony Stimulating Factor (G-CSF) Induced Bone Pain in Multiple Myeloma Patients Undergoing Stem Cell Mobilization.

The primary objective of this study is to evaluate the efficacy of the second-generation antihistamine, loratadine, as prophylaxis for filgrastim (i.e., Neupogen, Zarxio) induced bone pain during stem cell mobilization in multiple myeloma patients.

The secondary objectives are to (1) examine the frequency and quantity of supportive analgesic medications needed in addition to loratadine or placebo for filgrastim induced bone pain and (2) identify risk factors associated with developing filgrastim induced bone pain.

Protocol Number: 011910
Phase: Phase II
Applicable Disease Sites: Bones and Joints
Ill-Defined Sites
Multiple Myeloma
Drugs Involved: Loratadine/Placebo
Pegfilgrastim
Principal Investigator: Mansi R Shah
Scope: Local
Therapies Involved: Chemotherapy (NOS)
Chemotherapy multiple agents systemic
Participating Institutions:
  • RWJBarnabas Health
    • Robert Wood Johnson University Hospital, New Brunswick
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

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