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

Plasma Cell Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04211259
• Other study ID #: 011910
• Secondary ID: NCI-2019-07795Pr
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 18, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2023
• Source: Rutgers, The State University of New Jersey
• Contact: Mansi R. Shah, MD
• Phone: 732-235-4439
• Email: shahmr[@]cinj.rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 30, 2025
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Plasma Cell Myeloma

Intervention

Drug:
• Loratadine
Given PO

Other:
• Placebo
Given PO
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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