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

May 26, 2026 updated by: Mansi Shah, MD, Rutgers, The State University of New Jersey

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Baseline up to 5 days after completion of stem cell mobilization
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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2022

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

June 30, 2027

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)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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