Loratadine for the Reduction of G-CSF Induced Bone Pain in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization

ConditionPlasma Cell Myeloma

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorRutgers, The State University of New Jersey

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Loratadine
Drug
Given PO
Placebo
Other intervention
Given PO
Questionnaire Administration
Other intervention
Ancillary studies

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: Cohort I (loratadine)Experimental treatment 2 interventions

Group B: Cohort II (placebo)Placebo comparator 2 interventions

Trial outcomes

Primary outcomes

Change in mean pain level for each group following therapy

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.

Time frame

Baseline up to 5 days after completion of stem cell mobilization

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rutgers, The State University of New Jersey

Lead sponsor

Rutgers Cancer Institute of New Jersey

Sponsor institution

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

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