Using Loratadine to Prevent Bone Pain Caused by G-CSF During Stem Cell Collection in Multiple Myeloma Patients

What this Trial Is About

Researchers are evaluating loratadine, a second-generation antihistamine, for its ability to reduce bone pain caused by granulocyte-colony stimulating factor G-CSF during stem cell mobilization in patients with multiple myeloma. This early phase I trial aims to assess how well loratadine works to prevent this specific type of bone pain and to examine the need for other pain medications, as well as identify risk factors for developing G-CSF induced bone pain. Participants are randomly assigned to one of two groups one group receives loratadine orally once daily starting five days before the first dose of filgrastim and continuing until five days after stem cell mobilization completes, while the other group receives a placebo on the same schedule. Both treatments are given alongside standard care filgrastim, and the study maintains treatment unless disease progression or unacceptable side effects occur. During the study, participants will be monitored for changes in their pain levels from baseline through five days after stem cell mobilization. Researchers will also track the use of additional pain relief medications and assess safety throughout the trial. Questionnaires and other evaluations will be used to collect data, with the entire participation period covering the treatment phase and follow-up after stem cell collection.

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