Full Title
A Phase 1/2, Open-label, Multicenter Study to Evaluate a Dosing Regimen with Two Step-up Priming Doses and Longer Dosing Intervals of Elranatamab (PF-06863135) Monotherapy in Participants with Relapsed/Refractory Multiple MyelomaPurpose
The purpose of this study is to find the best dosing schedule of the drug elranatamab (PF-06863135) for people with multiple myeloma that has come back or continued to grow despite treatment. In a past study, elranatamab caused a common side effect called cytokine release syndrome (CRS), which occurs when a large amount of proteins called cytokines is released into the bloodstream. CRS may cause changes in blood pressure and heartbeat, flu-like symptoms (nausea, fever, and chills), and/or changes in the way the lungs, liver, or kidneys work.
Researchers are doing this study to find out whether elranatamab given on a new dosing schedule reduces the risk of CRS in people with recurrent or persistent multiple myeloma. Elranatamab is given as a subcutaneous (under the skin) injection.
Eligibility
To be eligible for this study, patients must meet several requirements, including:
- Participants must have multiple myeloma that has come back or continued to grow despite treatment.
- The serious side effects of prior therapies must go away before the study treatment is given.
- Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
- This study is for people age 18 or older.
Contact
For more information and to ask about eligibility for this study, please contact the office of Dr. Alexander Lesokhin at 646-608-3717.