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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04211259
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Rutgers, The State University of New Jersey
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Mansi R. Shah, MD
Principal Investigator Affiliation Rutgers Cancer Institute of New Jersey
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plasma Cell Myeloma
Additional Details

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.

Arms & Interventions

Arms

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.

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.

Interventions

Drug: - Loratadine

Given PO

Other: - Placebo

Given PO

Other: - Questionnaire Administration

Ancillary studies

Contact a Trial Team

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Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey

Status

Recruiting

Address

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

Site Contact

Mansi R. Shah, MD

shahmr@cinj.rutgers.edu

732-235-4439

New Brunswick, New Jersey

Status

Not yet recruiting

Address

RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick

New Brunswick, New Jersey, 08903