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

Sponsor

Rutgers, The State University of New Jersey (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04211259

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Plasma Cell Myeloma	Drug: Loratadine Other: Placebo Other: Questionnaire Administration	Early Phase 1

Detailed Description

PRIMARY OBJECTIVE:

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:

To examine the frequency and quantity of supportive analgesic medications needed in addition to loratadine or placebo for filgrastim induced bone pain.
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 Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

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.	Drug: Loratadine Given PO Other Names: Claritin Other: Questionnaire Administration Ancillary studies
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

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.

Drug: Loratadine

Given PO

Other Names:

Claritin

Other: Questionnaire Administration

Ancillary studies

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

Outcome Measures

Primary Outcome Measures

Change in mean pain level for each group following therapy [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08903

Sponsors and Collaborators

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

Investigators

Principal Investigator: Mansi R. Shah, MD, Rutgers Cancer Institute of New Jersey

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mansi Shah, MD, Assistant Professor of Medicine, Rutgers Cancer Institute of New Jersey

ClinicalTrials.gov Identifier:

NCT04211259

Other Study ID Numbers:

Pro2019001846
NCI-2019-07795
Pro2019001846
011910
P30CA072720

First Posted:

Dec 26, 2019

Last Update Posted:

May 26, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Loratadine

Study Results

No Results Posted as of May 26, 2022