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Prevention study for Stem Cell Transplant Complications
Official title Loratadine for the Prevention of G-CSF-related Bone Pain
ClinicalTrials.gov ID: NCT05421416
What this study is testing
What is Loratadine?
Loratadine is an investigational medicine, being studied as a potential treatment for stem cell transplant complications.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Hypersensitivity or intolerance to antihistamines
- Use of antihistamines within two days prior to the study period, excepting the use of single dose antihistamines during chemotherapy or blood...
- Recent use of G-CSF or pegfilgrastim defined as within 12 weeks of study accrual.
- New and continued regular use of analgesics within the four days prior to the first dose of G-CSF
See the full eligibility criteria
- 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...
- Able to adhere to study protocols and visit schedules
- Hypersensitivity or intolerance to antihistamines
- Use of antihistamines within two days prior to the study period, excepting the use of single dose antihistamines during chemotherapy or blood transfusion protocols.
- Recent use of G-CSF or pegfilgrastim defined as within 12 weeks of study accrual.
- New and continued regular use of analgesics within the four days prior to the first dose of G-CSF
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.