Daratumumab for Smoldering Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This research study is studying a drug as a possible treatment for Monoclonal Gammopathy of Unknown Significance (MGUS) or Smoldering Multiple Myeloma (SMM).The drug involved in this study is:-Daratumumab
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot take other treatments that are active against smoldering multiple myeloma or multiple myeloma while participating in this trial.
Is daratumumab safe for humans?
Daratumumab, also known as Darzalex, has been studied for safety in patients with multiple myeloma. Common side effects include low white blood cell counts (neutropenia), low platelet counts (thrombocytopenia), low red blood cell counts (anemia), pneumonia, and infusion-related reactions. Overall, it has an acceptable safety profile, especially when used in combination with other treatments.12345
What makes the drug Daratumumab unique for treating smoldering multiple myeloma?
Daratumumab is unique because it is a monoclonal antibody that specifically targets the CD38 protein on myeloma cells, leading to their destruction through various immune system mechanisms. It is also notable for its use in patients who have not responded to other treatments, offering a new option for those with limited alternatives.12367
What data supports the effectiveness of the drug Daratumumab for treating smoldering multiple myeloma?
Daratumumab has shown effectiveness in treating multiple myeloma, a type of blood cancer, by helping the immune system attack cancer cells. In studies, it has been effective as a single treatment and in combination with other drugs, showing rapid and lasting responses in patients with relapsed or hard-to-treat multiple myeloma.13678
Who Is on the Research Team?
Irene Ghobrial, MD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
Adults with high-risk MGUS or low-risk Smoldering Multiple Myeloma who haven't had treatment for these conditions can join. They must be in decent health, have certain blood and organ function levels, not be pregnant, and able to consent. Excluded are those with recent cancers (with exceptions), severe illnesses, major surgery within the last month, or on other clinical trials.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Daratumumab is administered by IV infusion weekly during cycles 1 and 2, every other week during cycles 3 through 6, and monthly during cycles 7 through 20
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Daratumumab
Daratumumab is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Janssen Pharmaceuticals
Industry Sponsor
Joaquin Duato
Janssen Pharmaceuticals
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Pharmaceuticals
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University
Multiple Myeloma Research Consortium
Collaborator
Blood Cancer Research Partnership
Collaborator
The Leukemia and Lymphoma Society
Collaborator