Study Comparing Daratumumab with VELCADE, Lenalidomide, and Dexamethasone (D-VRd) to VELCADE, Lenalidomide, and Dexamethasone (VRd) in Untreated Multiple Myeloma Patients Not Planning Stem Cell Transplant
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT03652064
This study is exploring whether adding the drug daratumumab to a standard treatment combination can improve outcomes for patients with newly diagnosed multiple myeloma who are not planning to undergo a stem cell transplant.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The aim of this study is to see if adding daratumumab to the standard treatment of bortezomib, lenalidomide, and dexamethasone (VRd) can better eliminate cancer cells in patients with newly diagnosed multiple myeloma who are not planning a stem cell transplant. Daratumumab targets a protein on myeloma cells, while bortezomib, lenalidomide, and dexamethasone work together to kill these cells. The study will use a subcutaneous form of daratumumab, which is expected to be as effective as the intravenous form but with fewer side effects. The study includes three phases: Screening, Treatment, and Follow-up, and will last about 6.5 years. Participants will undergo various tests and be monitored for side effects and treatment effectiveness.
Description
This study involves patients with newly diagnosed multiple myeloma who are not planning to have a stem cell transplant as their first treatment. The study will compare two treatment groups: one receiving the standard combination of bortezomib, lenalidomide, and dexamethasone (VRd), and the other receiving the same combination plus daratumumab (D-VRd). Daratumumab is a drug that targets a specific protein on myeloma cells, helping to destroy them. The study will use a subcutaneous form of daratumumab, which is expected to be as effective as the intravenous form but with fewer side effects. The study will last about 6.5 years and includes three phases: Screening, Treatment, and Follow-up. During the study, participants will have various tests to measure the amount of cancer in their body and monitor their health. They will also be closely watched for any side effects from the treatment.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with multiple myeloma, confirmed by specific medical criteria.
- Must have measurable disease as determined by lab tests.
- Performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
- Women of childbearing potential must have two negative pregnancy tests before starting treatment and agree not to donate eggs during the study and for three months after the last treatment dose.
Exclusion Criteria
- High frailty score according to specific assessment.
- Previous treatment for multiple myeloma, except for a short course of corticosteroids.
- Other invasive cancers within the last 5 years, except for certain skin cancers or other non-invasive cancers considered cured.
- Severe nerve pain or damage.
- Recent radiation therapy, except for specific cases of pain management.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.