Not Yet RecruitingPhase 2ACTRN12624001468516

A phase 2 study of the feasibility and efficacy of at home patient administered subcutaneous daratumumab in patients with relapsed multiple myeloma (Dara@Home)

Sponsor

Australasian Myeloma Research Consortium

Enrollment

50 participants

Start Date

Jan 1, 2025

Study Type

Interventional

Conditions

Relapsed refractory myeloma Myeloma

Summary

PURPOSE The purpose of this study is to assess the feasibility of patient self-administration of daratumumab in patient's own home. WHO IS IT FOR? You may be eligible for this study if you are male or female aged 18 years or older, have a documented diagnosis of multiple myeloma. Have relapsed following first line therapy and require treatment with daratumumab, bortezomib and dexamethasone. STUDY DETAILS Daratumumab, bortezomib and dexamethasone is standard of care. Daratumumab is currently administered in the hospital. Bortezomib can be administered home if your hospital has programs in place for this to happen. Dexamethasone is a tablet that you can take in your own home. The Dara@home trial is to assess the feasibility of implementing a program to allow patients to self-administer daratumumab at home. In addition to standard tests used to treat and monitor your myeloma, this study will have additional questionnaires for you to report your experience with myeloma treatment. There is also an additional blood test to assess the level daratumumab in your blood to ensure that the treatment is working. It is hoped that findings from this study will give insight on the possibility of having daratumumab to be self-administered at home, which can reduce your visits to the hospital.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria9

Males or females aged 18 years or older;
Have a documented diagnosis of MM according to the International Myeloma Working Group 2016 criteria (Rajkumar 2016);
Note: must include histological confirmation and have measurable disease
Have relapsed following first or subsequent-line therapy for MM and require treatment;
Relapse defined as per International Myeloma Working Group definitions
Have an ECOG performance score of 0, 1 or 2;
Are considered suitable for treatment with daratumumab (in the opinion of the Investigator);
In the opinion of the Investigator, are considered suitable for home self-administration (or carer administration); and
Have provided written informed consent.

Exclusion Criteria3

Have experienced NCI-CTCAE Grade 2 or worse peripheral neuropathy within the 14 days prior to enrolment;
Have any significant mobility issue that would preclude their ability to handle or deliver subcutaneous medications; or
Have significant cognitive impairment that, in the Investigator's opinion, would impede appropriate medication use.

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Interventions

The intervention is the self-administration of subcutaneous daratumumab at home. The intervention is planned for a total of 10 months. Trained site staff, such as a trial nurse or doctor, will conduct patient training on how to self-administer daratumumab and will monitor the self-administration in the clinic initially then over the phone once the administration is performed by patient at home. The dose of daratumumab is 1800mg per dose based on protocol schedule. Dosing schedule 35-day Treatment Weeks 1 to 9: - 1800 mg daratumumab subcutaneously weekly - Bortezomib 1.3mg per metre square subcutaneously on days 1, 8, 15 & 22 in a 35-day cycle - Dexamethasone 20mg orally on days 1, 2, 8, 9, 15, 16, 22, 23 in a 35-day cycle Treatment Weeks 10 to 24: 1800 mg daratumumab subcutaneously every three weeks (first dose is given at week 10) Bortezomib 1.3mg per metre square subcutaneously on days 1, 8, 15 & 22 in a 35-day cycle Dexamethasone 20mg orally on days 1, 2, 8, 9, 15, 16, 22, 23 in a 35-day cycle Treatment Weeks 25 to 40: - 1800 mg daratumumab subcutaneously every four weeks (first dose is of four-weekly dosing is given at week 25) - Bortezomib 1.3mg/m2 subcutaneously on days 1, 8, 15 & 22 in a 35-day cycle - Dexamethasone 20mg orally on days 1, 2, 8, 9, 15, 16, 22, 23 in a 35-day cycle Daratumumab treatment from Treatment Week 41 The self-administration program ceases. Daratumumab will be administered at per site standard of care treatment protocol. Treatment cycle is 28 days cycle. - 1800 mg daratumumab subcutaneously every four weeks (first dose is of four-weekly dosing is given at week 25)