The Prophylactic Use of Loratadine for Granulocyte-Colony Stimulating Factor (G-CSF) Induced Bone Pain in Multiple Myeloma Patients Undergoing Stem Cell Mobilization
Who is this study for? Patients with Plasma Cell Myeloma
What treatments are being studied? Questionnaire Administration
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
New Jersey
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick
NOT_YET_RECRUITING
New Brunswick
Contact Information
Primary
Mansi R. Shah, MD
shahmr@cinj.rutgers.edu
732-235-4439
Time Frame
Start Date: 2022-04-18
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 70
Treatments
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.
Authors
Related Therapeutic Areas
Sponsors
Leads: Rutgers, The State University of New Jersey
Collaborators: National Cancer Institute (NCI)