Page 11 - Delaware Medical Journal - May/June 2020

CTSU S1803: 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 (DRAMMATIC Study)
The objectives of the trial are:
Primary Endpoint:
• To compare overall survival (OS) between the two treatment arms with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm in post-autologous transplant multiple myeloma (MM) patients.
Secondary Endpoints:
• To compare the best overall response rate (ORR), including partial remission (PR), very good partial remission (VGPR), and complete remission (CR, sCR) in the subset of patients not in PR at randomization to lenalidomide versus lenalidomide + daratumumab/rHuPH20 in this patient population.
• To compare progression-free survival (PFS) between the study arms in this patient population.
• To evaluate MRD-negativity on the two treatment arms at randomization (Registration Step 2), and to compare MRD-negativity rate at 12, 24 (second randomization), 36, and 48 months after first randomization between lenalidomide and lenalidomide + daratumumab/ rHuPH20 in this patient population.
• To compare toxicities and tolerability of long-term therapy between the study arms.
Eligibility: Registration Step 1
• Patients must have had a confirmed diagnosis of symptomatic multiple myeloma that required systemic induction therapy prior to autologous stem cell transplantation.
• Patients with disease measurable by serum light chain assay alone are eligible (defined as ≥ 100 mg/L on involved light chain).
• Patients must not have progressive disease at any time prior to registration.
Prior/Concurrent Therapy Criteria Clinical/Laboratory Criteria
• Patients must have Zubrod Performance Status ≤ 2. Age ≥ 18 and ≤ 75 years at time of registration to Step 1. History and physical exam within 28 days prior to registration.
Registration Step 2 – First Randomization (Post-ASCT, Pre-Maintenance)
• Patients must have completed ASCT within 180 days prior to registering to Step 2.
• Patients must not have received any other maintenance therapy post-ASCT and prior to Step 2 registration.
• Patients must not have had progressive disease between induction and registration to Registration Step 2.
• Patients must have one of the following performed within 60 days prior to registration for disease assessment: diagnostic quality skeletal survey, whole body CT scan, MRI, or PET.
Clinical/Laboratory Criteria
• Zubrod Performance Status ≤ 2
Registration Step 3 – Second Randomization (Post 24 Months Maintenance)
• Patients must have completed 24 cycles of protocol maintenance with either lenalidomide or lenalidomide + daratumumab/rHuPH20.
Clinical/Laboratory Criteria
• Patients must be in very good partial remission (VGPR) or better by IMWG response criteria
Treatment: After Step 2; Randomized
Arm 1: Lenalidomide x 2 years
Arm 2: Lenalidomide + Daratumumab/rHuPH20 x 2 years
2-YEAR MRD ASSESSMENT
MRD Negative: Step 3; Second Randomization
Arm 1a: Continue Lenalidomide OR Arm 1b: Stop Lenalidomide
Arm 2a: Continue Lenalidomide + Daratumumab/rHuPH20 OR Arm 2b: Stop Lenalidomide + Daratumumab/rHuPH20 MRD Positive: Continue treatment
Contact your Research Nurse for further details.
For information regarding this clinical trial or if you would like to have the list of open protocols emailed to you, please call the Cancer Research Office at (302) 623-4450 or email akee@christianacare.org.
CANCER CLINICAL TRIAL
Del Med J | May/June 2020 | Vol. 92 | No. 3 107