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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2025
  • participants needed
    70
  • sponsor
    Rutgers, The State University of New Jersey
Updated on 21 October 2022
filgrastim
granulocyte colony stimulating factor
bone pain

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 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.

Details
Condition Plasma Cell Myeloma
Treatment questionnaire administration, Placebo, Loratadine
Clinical Study IdentifierNCT04211259
SponsorRutgers, The State University of New Jersey
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

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
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