NCT04211259

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Plasma Cell Myeloma

Interventions

Type	Name	Description
DRUG	Loratadine	Given PO
OTHER	Placebo	Given PO
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2022-04-18
• Primary completion: 2024-02-28
• Completion: 2025-06-30
• First posted: 2019-12-26
• Last updated: 2023-08-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study