The Prophylactic Use of Loratadine for Granulocyte-Colony Stimulating Factor (G-CSF) Induced Bone Pain in Multiple Myeloma Patients Undergoing Stem Cell Mobilization
Rutgers, The State University of New Jersey
Summary
This early phase I trial studies how well loratadine works in reducing granulocyte-colony stimulating factor (G-CSF) induced bone pain in patients with multiple myeloma who are undergoing stem cell mobilization. Loratadine is an antihistamine that may help to reduce or control bone pain during the process of stem cell collection in patients with multiple myeloma.
Description
PRIMARY OBJECTIVE: I. 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. SECONDARY OBJECTIVES: I. To examine the frequency and quantity of supportive analgesic medications needed in addition to loratadine or placebo for filgrastim induced bone pain. II. To identify risk factors associated with developing filgrastim induced bone pain. OUTLINE: Patients are randomized to 1 of 2 cohorts. COHORT I: Beginning 5 days before the first dos…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patient must be able to provide informed consent * Patients with confirmed diagnosis of multiple myeloma * Able to swallow and retain oral medication * All ethnic groups are eligible Exclusion Criteria: * Non-English speaking person * Patients undergoing haploidentical allogeneic hematopoietic stem cell transplant * Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds * Any medical complications or conditions that would, in the investigator's judgement, interfere with full participation in the study * On th…
Interventions
- DrugLoratadine
Given PO
- OtherPlacebo
Given PO
- OtherQuestionnaire Administration
Ancillary studies
Locations (2)
- Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey
- RWJBarnabas Health - Robert Wood Johnson University Hospital, New BrunswickNew Brunswick, New Jersey