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

Rutgers The State University of New Jersey

Status and phase: Enrolling; Early Phase 1

Conditions: Plasma Cell Myeloma

Treatments: Other: Placebo; Drug: Loratadine; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04211259

011910 (Other Identifier)

P30CA072720 (U.S. NIH Grant/Contract)

Pro2019001846

NCI-2019-07795 (Registry Identifier)

Details and patient eligibility

About

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.

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

70 participants in 2 patient groups, including a placebo group

Cohort I (loratadine)

Experimental group

Description:

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.

Treatment:

Drug: Loratadine

Other: Questionnaire Administration

Cohort II (placebo)

Placebo Comparator group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Placebo