This trial is testing Lenalidomide + Dexamethasone with or without Daratumumab to see if it can better treat patients with high-risk smoldering myeloma.
- Smoldering Plasma Cell Myeloma
2 Primary · 10 Secondary · Reporting Duration: Up to 15 years
Side Effects for
Awards & Highlights
2 Treatment Groups
Arm I (daratumumab, lenalidomide, dexamethasone)
1 of 2
Arm II (lenalidomide, dexamethasone)
1 of 2
288 Total Participants · 2 Treatment Groups
Primary Treatment: Daratumumab · No Placebo Group · Phase 3
Who is running the clinical trial?
Age 18+ · All Participants · 0 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
|Did not meet criteria||100.0%|
How many prior treatments have patients received?
Frequently Asked Questions
How many test subjects are actively participating in this experiment?
"Indeed, the clinicaltrials.gov website contains information indicating that this study is recruiting patients. This particular trial was first posted on April 30th, 2019 and was last edited on December 1st, 2021. A total of 288 participants are needed for the study, which is taking place at 100 different sites." - Anonymous Online Contributor
Are there any precedents for Daratumumab's usage in medical research?
"Manitoba Blood & Marrow Transplant Program CancerCare Manitoba was the first to study daratumumab in 2002. As of now, there are 1596 completed studies and 776 live trials being conducted, many of which taking place in Lakewood, Colorado." - Anonymous Online Contributor
What is the lofty goal of this clinical trial?
"The goal of this clinical trial is to measure overall survival (OS) over a 24-cycle treatment period (each cycle lasting 28 days). Secondary outcomes include the incidence of grade 3 or higher infusion-related reactions during cycle 1, as well as the rates of worst grade 3 or higher non-hematologic treatment-related events. Response rates of very good partial response (VGPR) or better and partial response (PR) or better will also be compared. ineligible patients are excluded from the analysis and unevaluable patients are counted in the denominator. Lastly, progression-free survival (PFS) will be estimated using the" - Anonymous Online Contributor
Has Daratumumab been cleared by the FDA?
"Daratumumab is considered safe according to our team's estimation, as it has received a score of 3. This is because phase 3 trials have shown some efficacy and multiple rounds of data supporting safety." - Anonymous Online Contributor
What are some of the key ways that Daratumumab has been shown to be effective?
"Most often, Daratumumab is used to treat ophthalmia and sympathetic. However, it has also been shown to be effective in treating branch retinal vein occlusion, macular edema, and at least two prior systemic chemotherapy regimens." - Anonymous Online Contributor