Plasma Cell Myeloma
Conditions
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.
Detailed description
PRIMARY OBJECTIVE: I. To evaluate the efficacy of the second-generation antihistamine, loratadine, as prophylaxis for filgrastim (i.e., Neupogen, Zarxio) induced bone pain during stem cell mobilization in multiple myeloma patients. SECONDARY OBJECTIVES: I. To examine the frequency and quantity of supportive analgesic medications needed in addition to loratadine or placebo for filgrastim induced bone pain. II. To identify risk factors associated with developing filgrastim induced bone pain. OUTLINE: Patients are randomized to 1 of 2 cohorts. COHORT I: Beginning 5 days before the first dose of standard of care filgrastim, patients receive loratadine orally (PO) once daily (QD). Treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity. COHORT II: Beginning 5 days before the first dose of standard of care filgrastim, patients receive placebo PO QD. Treatment continues until 5 days after completion of stem cell mobilization in the absence of disease progression or unacceptable toxicity.
Interventions
DRUGLoratadine
Given PO
OTHERPlacebo
Given PO
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean pain level for each group following therapy | 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. |
Countries
United States
Contacts
CONTACTMansi R. Shah, MD
PRINCIPAL_INVESTIGATORMansi R. Shah, MD
Rutgers Cancer Institute of New Jersey
Outcome results
None listed