Loratadine for the Reduction of G-CSF Induced Bone Pain in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization

Study Overview
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Brief Summary
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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.

Detailed Description
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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 dose of standard of care filgrastim, patients receive loratadine orally (PO) once daily (QD). Treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity. COHORT II: Beginning 5 days before the first dose of standard of care filgrastim, patients receive placebo PO QD. Treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity.

Official Title
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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

Conditions
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Plasma Cell Myeloma

Intervention / Treatment
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* Drug: Loratadine
* Other: Placebo
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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 therapeutic dose of aspirin (doses greater than 81 mg) within 7 days prior to the start of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort I (loratadine)<br>Beginning 5 days before the first dose of standard of care filgrastim, patients receive loratadine PO QD. Treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity. | Drug: Loratadine<br>* Given PO<br>* Other names: Claritin;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Placebo Comparator: Cohort II (placebo)<br>Beginning 5 days before the first dose of standard of care filgrastim, patients receive placebo PO QD. Treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity. | Other: Placebo<br>* Given PO<br>* Other names: sham therapy;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean pain level for each group following therapy | Pain severity will be measured at baseline and following treatment using a 10-point scale, with higher numbers indicating greater degrees of pain. Will compare the difference in mean pain level for each group following therapy. | Baseline up to 5 days after completion of stem cell mobilization |