NCT04211259 · Rutgers, The State University of New Jersey
Loratadine for the Reduction of G-CSF Induced Bone Pain in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Loratadine
Given PO
OTHER
Placebo
Given PO
OTHER
Questionnaire Administration
Ancillary studies
Primary outcome measures
Change in mean pain level for each group following therapy
Time frame: Baseline up to 5 days after completion of stem cell mobilization
Pain severity will be measured at baseline and following treatment using a 10-point scale, with higher numbers indicating greater degrees of pain. Will compare the difference in mean pain level for each group following therapy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- New Brunswick, New Jersey
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 29, 2026 · Source of record for eligibility and locations