Actively Recruiting
The Prophylactic Use of Loratadine for Granulocyte-Colony Stimulating Factor (G-CSF) Induced Bone Pain in Multiple Myeloma Patients Undergoing Stem Cell Mobilization
Led by Rutgers, The State University of New Jersey · Updated on 2026-05-29
70
Participants Needed
2
Research Sites
43 weeks
Total Duration
On this page
Sponsors
R
Rutgers, The State University of New Jersey
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating loratadine, a second-generation antihistamine, for its ability to reduce bone pain caused by granulocyte-colony stimulating factor (G-CSF) during stem cell mobilization in patients with multiple myeloma. This early phase I trial aims to assess how well loratadine works to prevent this specific type of bone pain and to examine the need for other pain medications, as well as identify risk factors for developing G-CSF induced bone pain. Participants are randomly assigned to one of two groups: one group receives loratadine orally once daily starting five days before the first dose of filgrastim and continuing until five days after stem cell mobilization completes, while the other group receives a placebo on the same schedule. Both treatments are given alongside standard care filgrastim, and the study maintains treatment unless disease progression or unacceptable side effects occur. During the study, participants will be monitored for changes in their pain levels from baseline through five days after stem cell mobilization. Researchers will also track the use of additional pain relief medications and assess safety throughout the trial. Questionnaires and other evaluations will be used to collect data, with the entire participation period covering the treatment phase and follow-up after stem cell collection.
CONDITIONS
Brief Title
Loratadine for the Reduction of G-CSF Induced Bone Pain in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 10 days or until 5 days after stem cell mobilization completion
Participants receive loratadine or placebo once daily starting 5 days before the first dose of standard care filgrastim and continuing until 5 days after completion of stem cell mobilization, to reduce G-CSF induced bone pain.
Daily medication with visits as per standard care schedules
Trial Site Locations
Total: 2 locations
1
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
2
RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick
New Brunswick, New Jersey, United States, 08903
Not Yet Recruiting
Research Team
M
Mansi R. Shah, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here