Home-Based Chemotherapy with Bortezomib for Multiple Myeloma

(EASE Trial)

Recruiting at 2 trial locations

Overseen By Amy Abel

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AHS Cancer Control Alberta

Must be taking: Bortezomib

Disqualifiers: Allergic reactions, Bleeding, Grade 3 side effects, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether people with multiple myeloma (a type of blood cancer) can safely receive bortezomib injections at home instead of in a hospital. The main goal is to determine if patients or their caregivers can administer these injections themselves after training. This trial suits those who have received multiple bortezomib injections in a hospital and feel comfortable trying home treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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 prior data suggests that home-based administration of bortezomib is safe?

Research shows that patients with multiple myeloma can safely and effectively administer bortezomib injections at home. With proper training, patients manage their treatment without frequent hospital visits. The FDA has already approved this method for treating multiple myeloma and certain lymphomas.

Safety data from studies involving over a thousand patients indicate that bortezomib is generally well-tolerated. Some patients might experience mild side effects, such as reactions at the injection site, but these are usually manageable and do not outweigh the benefits of home treatment. This makes self-injection a convenient option that could enhance the treatment experience for many. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for multiple myeloma, which often require patients to visit a clinic for administration, this new approach allows patients to self-administer bortezomib injections at home. This home-based delivery method provides greater convenience and flexibility, potentially improving patients' quality of life by reducing frequent hospital visits. Additionally, administering bortezomib subcutaneously (under the skin) may lead to fewer side effects compared to intravenous methods. Researchers are excited about this treatment because it could make managing multiple myeloma more accessible and comfortable for patients.

What evidence suggests that home-based administration of bortezomib is effective for multiple myeloma?

Research has shown that bortezomib effectively treats multiple myeloma, a type of blood cancer, especially when combined with other new treatments. Studies have found that injecting bortezomib under the skin causes fewer side effects, such as nerve damage, compared to intravenous administration. In this trial, participants will self-administer bortezomib at home, which is both cost-effective and preferred by patients over hospital visits. This approach suggests that self-injection at home could be a practical and convenient way to manage multiple myeloma. ^{3 6 7 8 9}

Who Is on the Research Team?

Jason Tay, MD

Principal Investigator

Arthur J.E. Child Comprehensive Cancer Centre

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Bortezomib Injection

Trial Overview 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.

How Is the Trial Designed?

Group I: Self Injection of Bortezomib Experimental Treatment 1 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

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta

Lead Sponsor

Trials

188

Recruited

26,900+

Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre

Collaborator

Trials

1

Recruited

100+

Arthur J.E. Child Comprehensive Cancer Centre

Collaborator

Trials

1

Recruited

100+

Tom Baker Cancer Centre

Collaborator

Trials

30

Recruited

8,900+

Published Research Related to This Trial

Bortezomib (Velcade) is an FDA-approved treatment for multiple myeloma and mantle cell lymphoma, available via both intravenous (IV) and subcutaneous (SC) injection, providing an option for patients with difficult IV access.

Strategies to minimize injection site reactions with SC administration are important for improving patient comfort and treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous administration of bortezomib: strategies to reduce injection site reactions. Kurtin, S., Knop, CS., Milliron, T.[2021]

Bortezomib is recommended for use in both newly diagnosed and relapsed/refractory multiple myeloma patients, whether they are eligible for autologous stem cell transplantation or not, based on a systematic review of evidence.

The guidelines also emphasize the importance of monitoring and managing potential toxicities associated with bortezomib treatment, such as the risk of herpes zoster reactivation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bortezomib in multiple myeloma: a practice guideline. Kouroukis, CT., Baldassarre, FG., Haynes, AE., et al.[2015]

Subcutaneous bortezomib is safe and effective for elderly and frail patients with multiple myeloma, showing a low incidence of adverse events and no emergency admissions, which helps reduce therapy discontinuation rates.

This treatment allows for self-administration at home, improving patients' quality of life by avoiding hospital visits while maintaining the efficacy of the bortezomib-melphalan-prednisone regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and comfort of domestic bortezomib injection in real-life experience. Cerchione, C., Nappi, D., Pareto, AE., et al.[2019]

Subcutaneous administration of bortezomib in 26 multiple myeloma patients showed similar efficacy to intravenous administration, with overall response rates of 75% and 71.43%, respectively, indicating it is an effective treatment option.

The subcutaneous method significantly reduced the incidence of peripheral neuropathy (16.67% vs. 64.29% in the intravenous group), enhancing safety while maintaining comparable treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Safety and efficacy of subcutaneous administration of bortezomib in the treatment of multiple myeloma]. Wang, YS., Ding, SH., Wu, F., et al.[2018]

In a study of 873 patients with relapsed/refractory multiple myeloma, bortezomib treatment resulted in a high overall response rate of 69%, with a median overall survival of 36.1 months, indicating its effectiveness in real-world clinical practice.

While bortezomib is effective, 51% of patients without prior neuropathy developed new-onset peripheral neuropathy by cycle 8, highlighting the importance of monitoring for adverse effects during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bortezomib-based therapy for relapsed/refractory multiple myeloma in real-world medical practice. Terpos, E., Katodritou, E., de la Rubia, J., et al.[2022]

Bortezomib significantly prolongs time to disease progression in multiple myeloma patients compared to high-dose dexamethasone, with a median progression time of 6.2 months versus 3.5 months, based on a phase 3 trial involving 669 patients.

The treatment with bortezomib also showed a higher response rate (38% complete plus partial response) compared to dexamethasone (18%), while the adverse events were consistent with previous studies, including issues like peripheral neuropathy and thrombocytopenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

United States Food and Drug Administration approval summary: bortezomib for the treatment of progressive multiple myeloma after one prior therapy. Kane, RC., Farrell, AT., Sridhara, R., et al.[2015]

Patients and healthcare professionals reported positive experiences with self-administration of subcutaneous Bortezomib at home, highlighting increased patient empowerment and satisfaction.

The study found that self-administration was feasible and safe, saving time for both patients and nurses, with only a slight increase in costs compared to hospital administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home is best. Self-administration of subcutaneous Bortezomib at home in patients with multiple myeloma - A mixed method study. Kirkegaard, J., Lundholm, BW., Rosenberg, T., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1462388922001077

Home is best. Self-administration of subcutaneous ... Home administration of bortezomib in multiple myeloma is cost-effective and is preferred by patients compared with hospital administration: results of a ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26578729/

Home administration of bortezomib in multiple myeloma is ... Conclusion: Home administration of s.c. bortezomib is cost-effective and is preferred by myeloma patients compared with hospital administration. Keywords: cost ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4094627/

Subcutaneous bortezomib for multiple myeloma treatment The use of novel agents such as thalidomide, lenalidomide, and bortezomib has considerably improved the outcome of multiple myeloma patients.

4. clinical-lymphoma-myeloma-leukemia.com clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(19)31905-6/fulltext

Bortezomib self-injection is time-saving, cost-neutral and ... Bortezomib self-injection is time-saving, cost-neutral and well received by patients with myeloma or AL amyloidosis: Results from the “SUBLIME” study. Simon ...

5. myeloma.org myeloma.org/velcade-bortezomib

Velcade (Bortezomib) & Multiple Myeloma Treatment | IMF Data on side effects from clinical trials with Velcade have demonstrated that SQ administration causes significantly less peripheral neuropathy (PN) than IV ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36162259/

Home is best. Self-administration of subcutaneous ... Self-administration of SC Bortezomib in the homes of patients with MM is advantageous for patients and healthcare professionals. It is feasible, safe, and ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/212782s000lbl.pdf

BORTEZOMIB INJECTION - accessdata.fda.gov Safety data from Phase 2 and 3 studies of single agent bortezomib 1.3 mg/m2/dose twice weekly for two weeks followed by a ten day rest period in 1163 patients ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4093357/

Strategies to Reduce Injection Site Reactions Bortezomib (Velcade) is approved by the FDA for IV or SC injection in select patients with multiple myeloma or mantle cell lymphoma.

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2014/021602s040lbl.pdf

3641334 This label may not be the latest approved by FDA ... The safety data described below and in. Table 11 reflect exposure to either VELCADE subcutaneous (n=147) or VELCADE intravenous (n=74). [see Clinical Studies ( ...