Home-Based Chemotherapy with Bortezomib for Multiple Myeloma
(EASE Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: AHS Cancer Control Alberta
Must be taking: Bortezomib
Disqualifiers: Allergic reactions, Bleeding, Grade 3 side effects, others
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial team or your doctor.
What data supports the effectiveness of the drug Bortezomib for treating multiple myeloma?
Bortezomib has been shown to be effective for treating multiple myeloma, as it received FDA approval based on a large international trial where it was compared to another treatment, showing its efficacy and safety. Additionally, real-world studies confirm its effectiveness and safety, especially when administered at home, which can improve patients' quality of life.
12345Is home-based chemotherapy with bortezomib safe for humans?
Research shows that bortezomib, when given as a subcutaneous (under the skin) injection at home, is generally safe for patients with multiple myeloma. The occurrence of side effects, like peripheral neuropathy (nerve damage causing pain or numbness), is low and does not typically require emergency care, making it a safe option for home treatment.
13456How is the drug Bortezomib unique for treating multiple myeloma?
Bortezomib is unique because it can be administered at home through a subcutaneous (under the skin) injection, which is more convenient and comfortable for patients, especially those who are elderly or frail. This home-based approach helps improve quality of life by reducing hospital visits without compromising the effectiveness of the treatment.
12357Eligibility 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 am able (or have someone who can) to give myself the treatment with instructions.
Signed informed consent
+2 more
Exclusion Criteria
Your doctor thinks you may not live for more than 6 months.
I am not in a clinical trial using bortezomib.
Deemed geographically inaccessible to receive care
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants self-administer subcutaneous bortezomib at home
2 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
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:
Arthur J.E. Child Comprehensive Cancer CentreCalgary, Canada
Cross Cancer InstituteEdmonton, Canada
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
Arthur J.E. Child Comprehensive Cancer CentreCollaborator
Tom Baker Cancer CentreCollaborator
References
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.
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.
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-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.
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.
[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.
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.