RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-04-18
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04211259

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient must be able to provide informed consent
  2. * Patients with confirmed diagnosis of multiple myeloma
  3. * Able to swallow and retain oral medication
  4. * All ethnic groups are eligible
  1. * Non-English speaking person
  2. * Patients undergoing haploidentical allogeneic hematopoietic stem cell transplant
  3. * Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds
  4. * Any medical complications or conditions that would, in the investigator's judgement, interfere with full participation in the study
  5. * On therapeutic dose of aspirin (doses greater than 81 mg) within 7 days prior to the start of the study

Contacts and Locations

Study Contact

Mansi R. Shah, MD
CONTACT
732-235-4439
shahmr@cinj.rutgers.edu

Principal Investigator

Mansi R. Shah, MD
PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey

Study Locations (Sites)

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick
New Brunswick, New Jersey, 08903
United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

  • Mansi R. Shah, MD, PRINCIPAL_INVESTIGATOR, Rutgers Cancer Institute of New Jersey

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-18
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2022-04-18
Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Plasma Cell Myeloma