Phase III study of daratumumab/rHuPH20 (NSC-810307) + lenalidomide or lenalidomide as post-autologous stem cell transplant maintenance therapy in patients with multiple myeloma (MM) using minimal residual disease to direct therapy duration (dramatic study)
The purpose of this part of the study (screening consent) is to allow the study doctor to follow the progress through transplant and see if the treatment portion is appropriate.
DiagnosisConfirmed diagnosis of symptomatic multiple myeloma that required systemic induction therapy prior to autologous stem cell transplantation.
Patients must have initiated induction therapy within 12 months prior to registration step 1 and have received at least two cycles of induction therapy.
Must not have received any investigational agents within 14 days prior to registration.
Patients must sign an approved informed consent and authorization permitting release of personal health information.
- ARM I: Lenalidomide for 2 years.
- ARM II: Lenalidomide + Daratumumab/rHPH20 for 2 years.
- Off protocol therapy for up to 7 years.
Patients will be followed for overall survival until 15 years from time of registration to registration step 2. Patients not registered to step 2 will not be followed.
For more information, visit ClinicalTrials.gov