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Loratadine for the Prevention of Bone Pain Caused by Granulocyte Colony Stimulating Factor (G-CSF) During Stem Cell Mobilization

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The research question for the current study is: Is loratadine more effective than placebo in preventing G-CSF-related bone pain during autologous hematopoetic stem cell transplant in patients with lymphoma or multiple myeloma? The hypothesis is that prophylaxis with loratadine will help prevent or reduce the severity of bone pain in this setting.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• A histologically or cytologically documented lymphoma or multiple myeloma

• Next line of therapy is autologous stem cell transplant

• Adult ≥ 18 years old.

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.

• Life expectancy of at least 12 weeks.

• The absence of any additional poorly controlled systemic disease that is directly contraindicated or places subject at significant risk, including but not limited to: congestive heart failure, diabetes mellitus, cirrhosis or liver failure, renal failure.

• Able to adhere to study protocols and visit schedules

Locations
Other Locations
Canada
Cross Cancer Institute
RECRUITING
Edmonton
Contact Information
Primary
Michael Chu, MD
Michael.Chu@ahs.ca
780-432-8757
Backup
Rammy Khadour
Rammy.Khadour@ahs.ca
780-432-8795
Time Frame
Start Date: 2024-11-28
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 78
Treatments
Experimental: Loratadine Arm
Loratadine 10mg, administered initially 3 hours before the first dose of G-CSF in the autologous stem cell mobilization protocol, and then daily for a minimum of 8 days.
Placebo_comparator: Placebo Arm
Placebo capsule, administered initially 3 hours before the first dose of G-CSF in the autologous stem cell mobilization protocol, and then daily for a minimum of 8 days.
Related Therapeutic Areas
Sponsors
Leads: AHS Cancer Control Alberta

This content was sourced from clinicaltrials.gov