NCT04211259 Loratadine for the Reduction of G-CSF Induced Bone Pain in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization
| NCT ID | NCT04211259 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Plasma Cell Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2022-04-18 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 70 participants in total. It began in 2022-04-18 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Mansi R. Shah, MD
PRINCIPAL INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Frequently Asked Questions
Who can join the NCT04211259 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Plasma Cell Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04211259 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04211259 currently recruiting?
Yes, NCT04211259 is actively recruiting participants. Contact the research team at shahmr@cinj.rutgers.edu for enrollment information.
Where is the NCT04211259 trial being conducted?
This trial is being conducted at New Brunswick, United States, New Brunswick, United States.
Who is sponsoring the NCT04211259 clinical trial?
NCT04211259 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Mansi R. Shah, MD at Rutgers Cancer Institute of New Jersey. The trial plans to enroll 70 participants.