Carbone Cancer Center Clinical Trials

Protocol No.	EAA181
Principal Investigator	Schmidt, Timothy
Phase	III
Age Group	Adult
ClinicalTrials.Gov	NCT04566328 (Click to jump to clinicaltrials.gov)
Management Group(s)	Myeloma; UWCCC 1 South Park; _External Institution(s)
Management Group(s)	Myeloma; UWCCC 1 South Park; _External Institution(s)
Title Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended For Early Autologous Transplantation Description A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation Objective The purpose of this study is to determine if, after receiving 9 cycles of the usual treatment with three drugs (daratumumab, lenalidomide and dexamethasone), adding bortezomib to the three drugs for the second set of 9 treatment cycles (cycles 10-18) could be more effective in shrinking your cancer or preventing it from returning, compared to continuing on the same three-drug combination for another 9 treatment cycles. But, it could also cause side effects. Treatment Daratumumab, lenalidomide and dexamethasone for 9 cycles (36 weeks) as your initial treatment. The length of one cycle of treatment is about 28 days. These first 9 cycles or 36 weeks of treatment are called induction treatment. After 9 cycles, you will have samples of your bone marrow, blood, and urine collected and tested to see whether or not you have any tumor remaining. After this assessment, you will be randomly assigned to receive either daratumumab, lenalidomide and dexamethasone with bortezomib added to the treatment, for 9 cycles; or you will continue on the same treatment with daratumumab, lenalidomide and dexamethasone for another 9 cycles. This second set of 9 cycles is called consolidation treatment. After completing 9 cycles of consolidation treatment, both groups will receive daratumumab and lenalidomide until either the disease progresses, side effects become too severe or intolerable, or you or your physician wish to stop treatment. Last stage of treatment is called maintenance treatment Key Eligibility Preregistration 18 years of age or older ECOG PS 0-2, PS 3 allowed if due to pain Newly diagnosed multiple myeloma by IMWG criteria Ineligible for autologous stem cell transplantation or willing to delay until first relapse or later Must be willing to undergo diagnostic bone marrow aspirate Must agree to register to the mandatory RevREMS program and be willing and able to comply with the requirements of RevREM Registration Must have received the Clonality (ID) test results from Adaptive Biotechnologies and dominant sequences must have been identified Must have standard risk multiple myeloma as defined by the protocol Must have measurable or evaluable disease as defined by the protocol Must have a SPEP UPEP, and serum FLC assay performed within 28 days prior to registration. In addition, a bone marrow biopsy and/or aspirate is required within 28 days if bone marrow is being followed for response Must have adequate organ and marrow function as defined by the protocol Can not be pregnant or breastfeeding and if childbearing potential must agree to adequate birth control as defined by the protocol Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization Chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated History of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load Cardiac disease as defined by the protocol History of DVT or PE must be taking anti-coagulation COPD must have FEV1 testing done Must not have moderate or severe asthma Randomization Institution must have received Tracking (MRD) test results from Adaptive Biotechnologies Must complete Step 1 induction phase Must not have received any non-protocol therapy outside of the assigned Step 1 Induction treatment including stem cell transplant ECOG PS 0-2, PS 3 allowed if due to pain Any adverse event(s) related to Step 1 Induction Treatment must have resolved to grade 2 or less Must have adequate organ and marrow function as defined by the protocol Can not be pregnant or breastfeeding Male and Female of childbearing potential must agree to adequate birth control as defined by the protocol Applicable Disease Sites Multiple Myeloma Participating Institutions UW Health 1 S. Park Medical Center; UW Health Carbone Cancer Center Rockford; UW Health Eastpark Medical Center; UW Health University Hospital; Wm. S. Middleton Memorial VA Hospital