RecruitingEarly Phase 1NCT04211259

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

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


Sponsor

Rutgers, The State University of New Jersey

Enrollment

70 participants

Start Date

Apr 18, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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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Interventions

DRUGLoratadine

Given PO

OTHERPlacebo

Given PO

OTHERQuestionnaire Administration

Ancillary studies


Locations(2)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick

New Brunswick, New Jersey, United States

View Full Details on ClinicalTrials.gov

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NCT04211259


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