S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration
NCT04071457
Age 18 - 75
Sex Both
Phase Phase 3
Third Opinion Trial Synopsis
In this clinical study, researchers are exploring a new treatment approach for patients with a specific type of blood cancer. The study is unique because it combines different therapies to see how well they work together. Here are some key points about the study:
- The treatment involves using a combination of drugs that target the cancer cells in different ways.
- Patients will receive the treatment in a specific order to maximize its effectiveness.
- The study aims to find out if this combination can improve patient outcomes compared to standard treatments.
- Researchers are also looking at how well patients tolerate the treatment and any side effects that may occur.
- This study includes a diverse group of participants to ensure the findings are applicable to a wide range of patients.
Third Opinion AI Generated Synopsis
Trial Summary
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years.
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years.
from ClinicalTrials.gov
Locations & Contact
Fill out the form and to let the Multiple Myeloma Research Foundation know you are interested in this trial.
Contacts:
Name: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Phone: 210-614-8808
Email: oncology.clinical.trials@marshfieldresearch.org
Phone: 210-614-8808
Name: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Phone: 800-782-8581
Name: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Phone: 800-782-8581
Name: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Phone: 800-782-8581
Name: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Phone: 800-782-8581
Name: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Phone: 800-782-8581
Name: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Phone: 800-782-8581
