Using loratadine to reduce bone pain from G-CSF in multiple myeloma patients during stem cell mobilization
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
Run by Rutgers, The State University of New Jersey · NCT04211259 · Data updated 2026-11-12
This study is testing if taking loratadine can help reduce bone pain in multiple myeloma patients who are receiving G-CSF during stem cell collection.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 2 sites (New Brunswick, New Jersey and 1 other locations) |
| Status | Recruiting |
| Started | April 18, 2022 |
| Main results expected | August 31, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | May 29, 2026 |
| Trial ID | NCT04211259 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with a confirmed diagnosis of multiple myeloma who are able to take oral medications.
✕Probably not a fit
Patients who are non-English speaking or have known allergies to the study medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early phase I trial investigates the effectiveness of loratadine, an antihistamine, in alleviating bone pain caused by granulocyte-colony stimulating factor (G-CSF) in patients with multiple myeloma undergoing stem cell mobilization. Participants are randomly assigned to receive either loratadine or a placebo starting five days before G-CSF treatment and continuing until five days after stem cell collection. The study aims to evaluate the efficacy of loratadine and assess the need for additional pain relief medications. Additionally, it seeks to identify risk factors for developing G-CSF induced bone pain.
Why it matters
Potential benefit: If successful, this study could provide a new method for managing bone pain in multiple myeloma patients during stem cell mobilization.
How similar studies have gone: While this approach is novel in the context of G-CSF induced bone pain, similar studies using antihistamines for pain management have shown promise.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
-
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States Recruiting -
RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick
New Brunswick, New Jersey, United States Not yet recruiting
Study contacts
- Principal investigator: Mansi R. Shah, MD — Rutgers Cancer Institute of New Jersey
- Study coordinator: Mansi R. Shah, MD
- Email: shahmr@cinj.rutgers.edu
- Phone: 732-235-4439
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Imaging for detecting cancer cells in multiple myeloma
This study is testing a new imaging agent to see if it can better detect cancer cells in people with multiple myeloma compared to standard imaging methods.
-
Comparing drug combinations for treating newly diagnosed multiple myeloma in patients not suitable for stem cell transplant
This study is testing different combinations of three drugs to see which works best for people with newly diagnosed multiple myeloma who can't have a stem cell transplant.
-
Improving quality of life and immune function in multiple myeloma patients through lifestyle changes
This study is testing whether lifestyle changes like exercise and diet can improve the immune system and quality of life for people with multiple myeloma.
-
Combination treatment for high-risk myeloma using belantamab mafodotin, pomalidomide, and dexamethasone
This study is testing a new combination of three medications to see if it can help people with high-risk plasma cell myeloma feel better and improve their treatment outcomes.
-
Assessing cognitive effects of whole brain radiation therapy in blood cancer patients
This study is testing how whole brain radiation therapy affects thinking and memory in blood cancer patients, while also looking at quality of life and brain changes over time.
-
Combining four drugs to treat newly diagnosed multiple myeloma
This study is testing if adding a fourth drug to a three-drug treatment helps adults with newly diagnosed multiple myeloma live longer and feel better.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.