Daratumumab Injection for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method of administering daratumumab, a drug that targets and destroys abnormal plasma cells in conditions like multiple myeloma and AL amyloidosis. Researchers aim to determine if injecting this medicine in the thigh is as effective and less painful than the usual abdominal injection. Individuals with a confirmed diagnosis of multiple myeloma or AL amyloidosis, who plan to start daratumumab treatment and haven't received it recently, might be suitable candidates. Participants will receive the treatment once a week for eight weeks. As a Phase 1, Phase 2 trial, this research seeks to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications. However, you cannot have had systemic anti-myeloma therapy within 14 days before starting the study drug.
What prior data suggests that daratumumab is safe for subcutaneous administration in the thigh or abdomen?
Research has shown that subcutaneous daratumumab is generally well-tolerated by patients. In one study involving patients with high-risk smoldering multiple myeloma, 28% experienced reactions at the injection site. Most reactions were mild, with only a few being moderate.
The FDA has approved daratumumab for treating multiple myeloma and light chain amyloidosis, indicating its safety for humans. While side effects can occur, such as injection site reactions, the drug has proven effective and manageable for many patients.
This study examines whether injecting the drug in the thigh is as effective as injecting it in the abdomen, without introducing new safety issues.12345Why are researchers excited about this trial's treatment?
Daratumumab is unique because it offers a new delivery method for treating multiple myeloma. Unlike traditional intravenous options, daratumumab in this trial is administered subcutaneously, either in the abdomen or the anterior upper thigh, which can potentially offer more convenience and comfort for patients. This method is exciting as it may allow for easier administration and possibly fewer side effects, while maintaining or improving efficacy compared to existing treatments. Researchers are eager to see if these benefits translate into better patient outcomes.
What is the effectiveness track record for daratumumab in treating multiple myeloma?
Research has shown that daratumumab effectively treats multiple myeloma, a type of blood cancer. Adding daratumumab to standard treatment reduced the risk of cancer progression or death by nearly 60%. Patients receiving daratumumab as an injection under the skin demonstrated a 52% overall response rate, with benefits lasting over a year on average. This subcutaneous method is also easier and quicker than the traditional intravenous method. In this trial, one group of participants will receive the injection in the thigh, while another group will receive it in the abdomen, to evaluate if thigh administration is as beneficial as abdomen administration.678910
Who Is on the Research Team?
Ashraf Badros, MD
Principal Investigator
University of Maryland, Baltimore Greenebaum Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with plasma cell disorders like multiple myeloma, who haven't had daratumumab recently or at all. They should be relatively healthy (ECOG 0-2), not pregnant, and if they can have children, must use effective birth control. People with active infections or poor organ function cannot join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Subcutaneous administration of daratumumab in the thigh or abdomen weekly for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Daratumumab
Trial Overview
The study tests the safety and effectiveness of giving daratumumab injections in the thigh versus the abdomen. Daratumumab is an FDA-approved antibody treatment for certain blood cancers that's usually injected into the abdomen; this trial explores thigh injection as a potentially less painful alternative.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Treatment will be given for 8 weeks. SC Daratumumab will be administered in the thigh weekly for 8 weeks. Patients may receive daratumumab alone or in combination with standard of care regimen
Treatment will be given for 8 weeks. SC Daratumumab will be administered in the abdomen weekly for 8 weeks. Patients may receive daratumumab alone or in combination with standard of care regimen
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor
Johnson & Johnson
Industry Sponsor
Citations
Daratumumab Plus Standard Therapy for Multiple Myeloma
Adding daratumumab to the standard treatment resulted in a nearly 60% drop in the risk of cancer progression or death (hazard ratio of 0.42), ...
Subcutaneous daratumumab in patients with relapsed or ...
At a median follow-up of 14.2 months, the overall response rate was 52%, the median duration of response was 15.7 months, and the median progression-free ...
3.
ashpublications.org
ashpublications.org/ashclinicalnews/news/1930/Subcutaneous-Delivery-of-Daratumumab-Is-SafeSubcutaneous Delivery of Daratumumab Is Safe, Effective in ...
"Subcutaneous daratumumab administration appears safe, effective, and convenient for patients in an approximately 30-minute infusion time for ...
4.
jons-online.com
jons-online.com/special-issues-and-supplements/2020/june-2020-clinical-trials-to-clinical-practiceSubcutaneous Daratumumab for Multiple Myeloma
The primary efficacy end points were met for all 3 groups (see Table 2).19 The ORR rates were 88.1% and 90.8% in newly diagnosed, transplant-ineligible patients ...
Short observation time after subcutaneous Daratumumab ...
SC daratumumab has several advantages over the IV formulation with significantly shorter administration time, lower rates of systemic reactions, and smaller ...
Real-world data on the use of subcutaneous daratumumab ...
Results from this noninterventional, multicenter, observational study provide evidence for the clinical efficacy and safety of daratumumab SC in ...
DARZALEX FASPRO® is the first and only treatment ...
Phase 3 AQUILA study showed DARZALEX FASPRO® significantly reduced the risk of progression to active multiple myeloma or death by 51 percent ...
Clinical Administration Characteristics of Subcutaneous ...
Median duration of daratumumab (DARA) administration for treatment of multiple myeloma is 3-7 hours for the intravenous formulation (DARA IV) and 3-5 minutes ...
Administration
In patients with high-risk smoldering multiple myeloma (N=193), injection-site reactions occurred in 28% of patients, including Grade 2 reactions in 3%. These ...
10.
onclive.com
onclive.com/view/fda-approves-subcutaneous-daratumumab-for-high-risk-smoldering-multiple-myelomaFDA Approves Subcutaneous Daratumumab for High-Risk ...
The 60-month OS rates were 93.0% for the daratumumab arm vs 86.9% for the monitoring arm. Additionally, daratumumab was associated with ...
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