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

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. ^{1 2 3 4 5}

Is 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. ^{1 3 4 5 6}

How 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. ^{1 2 3 5 7}

Research Team

Jason Tay, MD

Principal Investigator

Arthur J.E. Child Comprehensive Cancer Centre

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 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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Subcutaneous administration of bortezomib: strategies to reduce injection site reactions. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Bortezomib in multiple myeloma: a practice guideline. [2015]

3. United States 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. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Bortezomib-based therapy for relapsed/refractory multiple myeloma in real-world medical practice. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Safety and comfort of domestic bortezomib injection in real-life experience. [2019]

6. China pubmed.ncbi.nlm.nih.gov

[Safety and efficacy of subcutaneous administration of bortezomib in the treatment of multiple myeloma]. [2018]

7. Scotland pubmed.ncbi.nlm.nih.gov

Home is best. Self-administration of subcutaneous Bortezomib at home in patients with multiple myeloma - A mixed method study. [2022]