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Monoclonal Antibodies
Subcutaneous Daratumumab for High-Risk Smoldering Multiple Myeloma
Phase 3
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Diagnosis of high risk smoldering multiple myeloma (SMM) (per International Myeloma Working Group [IMWG] criteria) for less than or equal to (<=) 5 years with measurable disease at the time of randomization, defined as serum M protein greater than or equal to (>=) 10 gram per liter (g/L) or urine M protein >= 200 milligram per 24 hours (mg/24 hours) or involved serum free light chain (FLC) >=100 milligram per liter (mg/L) and abnormal serum FLC ratio
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 8 years
Awards & highlights
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.
Who is the study for?
This trial is for people diagnosed with high-risk smoldering multiple myeloma (SMM) within the last 5 years, who have measurable disease and meet specific criteria like certain protein levels in blood/urine. They should be relatively healthy otherwise, able to perform daily activities with little or no assistance (ECOG score of 0 or 1), and women must use effective contraception. People can't join if they've had previous treatments for SMM/MM, certain bone lesions, severe kidney issues, recent other cancers except minor skin cancers or localized prostate cancer.Check my eligibility
What is being tested?
The study tests whether daratumumab given under the skin prolongs the time patients live without their disease getting worse compared to just watching and waiting. Daratumumab is an antibody that targets cancer cells. Participants will either receive this drug subcutaneously along with rHuPH20 (an enzyme to help absorption) or undergo active monitoring without treatment.See study design
What are the potential side effects?
Daratumumab may cause side effects such as reactions at the injection site, fatigue, nausea, fever, chills, coughing and shortness of breath during infusion; it can also affect blood cell counts increasing infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I have been diagnosed with a high-risk type of early-stage multiple myeloma within the last 5 years.
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I am using or willing to use effective birth control or abstain from sex.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 8 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free Survival (PFS)
Secondary outcome measures
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
Change From Baseline in European Quality (EuroQoL) 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale
+14 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B: Daratumumab SCExperimental Treatment1 Intervention
Participants will receive 1800 milligram (mg) of daratumumab co-formulated with 2000 units per milliliter (U/mL) of recombinant human hyaluronidase (rHuPH20) by subcutaneous (SC) injection until 39 cycles or up to 36 months or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment, study termination or study completion.
Group II: Arm A: Active MonitoringActive Control1 Intervention
Participants randomized to active monitoring will receive no study medication, but will undergo the same disease evaluations at the same frequency as participants randomized to daratumumab.
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Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
976 Previous Clinical Trials
6,384,302 Total Patients Enrolled
70 Trials studying Multiple Myeloma
19,072 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
746 Previous Clinical Trials
3,959,888 Total Patients Enrolled
49 Trials studying Multiple Myeloma
14,039 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: Daratumumab SC
- Group 2: Arm A: Active Monitoring
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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