Multiple Myeloma Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

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 is for people with:

Multiple Myeloma

Phase:

Early Phase 1

Estimated Enrollment:

70

Study ID:

NCT04211259

Recruitment Status:

Recruiting

Sponsor:

Rutgers, The State University of New Jersey

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There is 1 Location for this study

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Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States More Info
Mansi R. Shah, MD
Contact
732-235-4439
[email protected]
Mansi Shah
Principal Investigator
RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick
New Brunswick New Jersey, 08903, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Early Phase 1

Estimated Enrollment:

70

Study ID:

NCT04211259

Recruitment Status:

Recruiting

Sponsor:


Rutgers, The State University of New Jersey

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