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

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.

Study Overview

• Status: Recruiting
• Conditions: Plasma Cell Myeloma
• Intervention / Treatment: Other: Placebo; Other: Questionnaire Administration; Drug: Loratadine

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Mansi R. Shah, MD; Phone Number: 732-235-4439; Email: shahmr@cinj.rutgers.edu

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Recruiting
      • Rutgers Cancer Institute of New Jersey
      • Contact: Mansi R. Shah, MD; Phone Number: 732-235-4439; Email: shahmr@cinj.rutgers.edu
      • Principal Investigator: Mansi Shah
    • New Brunswick, New Jersey, United States, 08903
      • Not yet recruiting
      • RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort I (loratadine); Beginning 5 days before the first dose of standard of care filgrastim, patients receive loratadine PO QD. Treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity.	Other: Questionnaire Administration; Ancillary studies; Drug: Loratadine; Given PO; Other Names: Claritin
Placebo Comparator: Cohort II (placebo); 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.	Other: Placebo; Given PO; Other Names: placebo therapy; PLCB; sham therapy; Other: Questionnaire Administration; Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Mansi R. Shah, MD, Rutgers Cancer Institute of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2022
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: December 23, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Histamine H1 Antagonists, Non-Sedating; Loratadine
• Other Study ID Numbers: 011910 (Rutgers Cancer Institute of New Jersey); P30CA072720 (U.S. NIH Grant/Contract); Pro2019001846 (Other Identifier: Rutgers Cancer Institute of New Jersey); NCI-2019-07795 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No