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

Last updated: August 3, 2023
Sponsor: Rutgers, The State University of New Jersey
Overall Status: Active - Recruiting

Phase

1

Condition

Leukemia

Lymphoproliferative Disorders

Bone Neoplasm

Treatment

Loratadine

Questionnaire Administration

Placebo

Clinical Study ID

NCT04211259
011910
Pro2019001846
P30CA072720
NCI-2019-07795
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 thestart of the study

Study Design

Total Participants: 70
Treatment Group(s): 3
Primary Treatment: Loratadine
Phase: 1
Study Start date:
April 18, 2022
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08903
    United States

    Active - Recruiting

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