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Subcutaneous Daratumumab for High-Risk Smoldering Multiple Myeloma
Study Summary
This trial will compare the effects of a new medication given as a shot under the skin to active monitoring in people with a high risk of developing a blood cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have more than one small spot in your body that is bigger than 5 millimeters when checked with MRI.My kidney function is low, not due to multiple myeloma.I have previously received treatments for SMM or MM, but I am on stable doses of medication for bone health.I have anemia but haven't received blood transfusions or erythropoietin treatment.I have previously been treated with daratumumab or other anti-CD38 therapies.I have been diagnosed with a high-risk type of early-stage multiple myeloma within the last 5 years.If you are a woman who could become pregnant, you need to have a negative pregnancy test within 14 days before starting the study.I have multiple myeloma with bone damage or old bone injuries.My calcium levels are higher than normal, but it's not due to multiple myeloma.I have not used any experimental drugs or devices in the last 4 weeks or longer.I am currently taking more than 10mg of corticosteroids daily or have taken a high dose in the past year.I am not currently on treatments like infliximab or methotrexate that could affect the study.I am fully active or can carry out light work.I haven't had treatment for cancer, except for minor skin cancers or early-stage cervical or breast cancer, in the last 3 years.You have allergies or bad reactions to corticosteroids, monoclonal antibodies, hyaluronidase, or other human proteins, or any ingredients in these medications.The ratio of certain proteins in your blood is too high.You have a high percentage of abnormal plasma cells in your bone marrow.I have been diagnosed with AL amyloidosis.My bone marrow has more than 10% cancer cells and I have at least one other risk factor.I am using or willing to use effective birth control or abstain from sex.
- Group 1: Arm B: Daratumumab SC
- Group 2: Arm A: Active Monitoring
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are new test subjects needed for this experiment?
"Although this study is no longer admitting patients, it was last edited on 11/3/2022. If you are looking for other studies, 827 trials for smoldering multiple myeloma and 172 daratumumab SC: daratumumab + rHuPH20 trials are still recruiting participants."
Are there many examples of daratumumab SC working in unison with rHuPH20?
"There are a total of 172 clinical studies investigating the efficacy of Daratumumab SC: daratumumab + rHuPH20. Of those, 35 are currently in Phase 3. While many of the studies for this treatment are based in Harrison, New york, there are 7146 locations running clinical trials for this medication globally."
Has the FDA cleared Daratumumab SC: daratumumab + rHuPH20 for use?
"Daratumumab SC: daratumumab + rHuPH20 has some efficacy data from Phase 3 clinical trials and multiple rounds of safety data, so it is estimated to be a safe medication."
For what condition is Daratumumab SC: daratumumab + rHuPH20 most commonly prescribed?
"Daratumumab SC: daratumumab + rHuPH20 is indicated for the treatment of amyloidosis and other disorders such as refractory multiple myeloma, relapsed or refractory multiple myeloma, and cell transplants."
How many subjects are participating in this clinical trial?
"This study is not looking for new participants at the moment. However, it's worth noting that the trial was first posted on 11/7/2017 and last edited on 11/3/2022. For patients seeking other studies, 827 clinical trials are actively enrolling patients with smoldering multiple myeloma and 172 trials for Daratumumab SC: daratumumab + rHuPH20 are actively recruiting right now."
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