Clinical trial NCT04211259: Loratadine for the Reduction of G-CSF Induced Bone Pain in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Plasma Cell Myeloma
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-12-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Change in mean pain level for each group following therapy
timeFrame: Baseline up to 5 days after completion of stem cell mobilization
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: New Brunswick
country: United States
facility: RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Mansi R. Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: