A Randomized, Double-blind, Placebo-Controlled Phase II Trial of an Allogeneic Myeloma GM-CSF Vaccine With Lenalidomide in Multiple Myeloma Patients in Complete or Near Complete Remission
Syed abbas Ali
Johns Hopkins Kimmel Cancer Center in Baltimore
The purpose of this study is to determine whether using the GVAX myeloma vaccine can improve responsiveness to drug lenalidomide.
To be eligible, individuals must have measurable multiple myeloma, be over 18 years of age, have good to moderate physical performance capabilities and have at least 12 month life expectancy, have a history of M protein, have good organ function, not have other diseases, be registered with the Revlimid REMS program, not be pregnant, be able to take prophylactic anticoagulants.
This is a two-arm, randomized controlled, Phase II study examining the clinical benefit of a myeloma vaccine alone, or in combination with lenalidomide. Patients enrolled in the study must have two disease measurements (including the last one) consistent with a near complete remission (M-spike negative with persistence of immunofixation), or complete remission (M-spike negative, negative immunofixation, and less than 5% clonal plasma cells on bone marrow) per criteria for response in a 3 month period. Prior to enrollment, patients will have been treated with a lenalidomide containing regimen for a minimum of 6 cycles. All patients will continue on a standard dose of lenalidomide as a single agent until progression, or treatment limiting toxicity, following enrollment. Patients will be randomized to receive either lenalidomide alone or in combination with vaccine. Patients assigned to vaccine therapy will receive injections on day 14 (+/-3 days) of cycles 1, 2, 3 and 6 from enrollment, and then annually thereafter. All patients will be followed for a minimum of 3 years.
01/17/2020 05:03 AM