Home-Based Chemotherapy with Bortezomib for Multiple Myeloma (EASE Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: AHS Cancer Control Alberta
No Placebo Group
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This study is to see if the standard of care subcutaneous injection of bortezomib can safely be administered at home by the patient or caregiver. All tests and assessments are based on standard of care procedures.
What data supports the idea that Home-Based Chemotherapy with Bortezomib for Multiple Myeloma is an effective drug?The available research shows that Bortezomib is effective for treating multiple myeloma, especially in patients who have already tried other treatments. The FDA approved Bortezomib based on a large study where it was compared to another drug, and it showed positive results. Additionally, real-world studies confirm that using Bortezomib at home is safe and effective, especially for elderly and frail patients, and it helps improve their quality of life by reducing hospital visits.12456
What safety data exists for home-based bortezomib treatment in multiple myeloma?Safety data for home-based bortezomib treatment in multiple myeloma indicates that subcutaneous administration is generally safe, with a low incidence of adverse events such as peripheral neuropathy. Studies suggest that this method does not require emergency services and reduces therapy discontinuation rates, making it a viable option for elderly and frail patients. The FDA has approved bortezomib for multiple myeloma, and strategies exist to minimize injection site reactions. Overall, home-based treatment can improve patient quality of life without compromising efficacy.13456
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
Is the drug Bortezomib Injection a promising treatment for Multiple Myeloma?Yes, Bortezomib Injection is a promising treatment for Multiple Myeloma. It has been approved by the FDA for its effectiveness and safety. Patients can even administer it at home, which makes treatment more convenient and can improve their quality of life. It is effective for patients who have tried other treatments before, and it can be given in a way that reduces discomfort from injections.12457
Eligibility Criteria
This trial is for adults over 18 with symptomatic myeloma who've had at least four bortezomib injections in a medical setting. They must be stable, willing, and able to self-administer the drug or have a caregiver do it. People can't join if they're not likely to follow treatment, have less than six months to live, are hard to reach for care, allergic to bortezomib, in another bortezomib study, or had severe side effects from it before.Inclusion Criteria
I am 18 or older with diagnosed symptomatic myeloma.
I have had more than 4 bortezomib injections in a hospital or cancer center.
Exclusion Criteria
I am not in a clinical trial using bortezomib.
I have had bleeding problems due to bortezomib.
I have experienced severe side effects from bortezomib.
Treatment Details
The trial tests if patients with multiple myeloma or plasma cell neoplasms can safely give themselves the chemotherapy drug bortezomib at home. It's checking whether this approach is as safe as when given in a hospital by healthcare professionals.
1Treatment groups
Experimental Treatment
Group I: Self Injection of BortezomibExperimental Treatment1 Intervention
Subcutaneous self administration of bortezomib
Bortezomib Injection is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Velcade for:
- Multiple myeloma
- Mantle cell lymphoma
🇺🇸 Approved in United States as Velcade for:
- Multiple myeloma
- Mantle cell lymphoma
Find a clinic near you
Research locations nearbySelect from list below to view details:
Tom Baker Cancer CentreCalgary, Canada
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Who is running the clinical trial?
AHS Cancer Control AlbertaLead Sponsor
Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer CentreCollaborator
Tom Baker Cancer CentreCollaborator
References
United States Food and Drug Administration approval summary: bortezomib for the treatment of progressive multiple myeloma after one prior therapy. [2015]On March 25, 2005, bortezomib (Velcade for Injection; Millennium Pharmaceuticals, Inc., Cambridge, MA, and Johnson & Johnson Pharmaceutical Research & Development, L.L.C.) received regular approval from the U.S. Food and Drug Administration (U.S. FDA) for the treatment of multiple myeloma (MM) progressing after at least one prior therapy. This approval was based on bortezomib's efficacy and safety which was shown in a single, large, comparative international open-label phase 3 trial that randomized 669 patients with MM previously treated with at least one systemic regimen to receive single-agent bortezomib or high-dose dexamethasone. The FDA analysis of the trial data and bortezomib's regulatory development are summarized here.
Bortezomib in multiple myeloma: a practice guideline. [2015]Bortezomib (Velcade™, PS-341), a first-in-class proteasome inhibitor, has been extensively studied either alone or in combination with other agents for the treatment of multiple myeloma. We created a provincial guideline for the use of bortezomib, in newly diagnosed individuals (both eligible and ineligible for transplant) and in individuals with relapsed or refractory multiple myeloma.
[Safety and efficacy of subcutaneous administration of bortezomib in the treatment of multiple myeloma]. [2018]To analyze the efficacy and safety of subcutaneous administration of bortezomib in the treatment of multiple myeloma (MM) patients.
Subcutaneous administration of bortezomib: strategies to reduce injection site reactions. [2021]Bortezomib (Velcade) is approved by the FDA for IV or SC injection in select patients with multiple myeloma or mantle cell lymphoma. The SC route functions as an alternative to IV administration for patients with poor IV access. Learn about effective strategies used to reduce injection site reactions that can occur with SC delivery.
Safety and comfort of domestic bortezomib injection in real-life experience. [2019]Despite novel agents, multiple myeloma is still an incurable disease, especially for elderly and frail patients, who are difficult to manage for concomitant comorbidities as the therapeutic options are limited and the response to chemotherapy is often short. We report our evaluations upon safety and efficacy of domestic subcutaneous bortezomib in elderly and frail patients candidate to bortezomib-melphalan-prednisone (VMP) regimen. We confirmed that overall incidence of adverse events, including peripheral neuropathy, was low, and in no case required admission to emergency service, contributing to reduce the rate of therapy discontinuation. These results confirm the effectiveness and safety of subcutaneous bortezomib, in a real-life-experience, and define a new possibility of safe auto-administration in a comfortable domestic setting. We suggest that domestic treatment can significantly improve the quality of life of the patients, avoiding unnecessary transfer to the hospital without reducing treatment efficacy.
Bortezomib-based therapy for relapsed/refractory multiple myeloma in real-world medical practice. [2022]Label="OBJECTIVE" NlmCategory="OBJECTIVE">The efficacy and safety of bortezomib-based therapy for relapsed/refractory multiple myeloma (RRMM) in clinical trials may differ from the oncology practice experience. The electronic VELCADE® OBservational Study was designed to prospectively evaluate bortezomib for multiple myeloma (MM) in real-world medical practice.
Home is best. Self-administration of subcutaneous Bortezomib at home in patients with multiple myeloma - A mixed method study. [2022]To examine the perspectives of patients and healthcare professionals of self-administration of subcutaneous (SC) injection of Bortezomib in the homes of patients with Multiple Myeloma (MM), and to assess organizational aspects.