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Trial registered on ANZCTR


Registration number
ACTRN12624001468516
Ethics application status
Approved
Date submitted
4/07/2024
Date registered
18/12/2024
Date last updated
18/12/2024
Date data sharing statement initially provided
18/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A phase 2 study of the feasibility and efficacy of at home patient administered subcutaneous daratumumab in patients with relapsed multiple myeloma (Dara@Home)
Scientific title
A phase 2 study of the feasibility and efficacy of at home patient administered subcutaneous daratumumab in patients with relapsed multiple myeloma (Dara@Home)
Secondary ID [1] 312462 0
AMaRC 21-03
Universal Trial Number (UTN)
Trial acronym
Dara@Home
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myeloma 334295 0
Multiple myeloma 334296 0
Relapsed refractory myeloma 334297 0
Condition category
Condition code
Cancer 330951 330951 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
Intervention code [1] 328969 0
Treatment: Other
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338722 0
Composite primary outcome: To determine the feasibility and deliverability of self-administration at home of daratumumab by participants with relapsed, refractory multiple myeloma
Timepoint [1] 338722 0
End of cycle 8 (10 months) post-intervention commencement
Secondary outcome [1] 437118 0
To assess the safety of self-administration at home of daratumumab by participants with relapse refractory multiple myeloma.
Timepoint [1] 437118 0
Adverse events reported from consent through to 28 days after last protocol-specified self-administered dose
Secondary outcome [2] 437119 0
To assess the efficacy of self-administration at home of daratumumab by participants with relapsed, refractory multiple myeloma
Timepoint [2] 437119 0
After patient reaches cycle 8 (10 months) or withdraws earlier
Secondary outcome [3] 437120 0
To assess participant satisfaction with self-administration at home of daratumumab by participants with RRMM.
Timepoint [3] 437120 0
After patient reaches cycle 8 (10 months) or withdraws earlier
Secondary outcome [4] 437122 0
To calculate the deliverability of home administration of dartumumab.
Timepoint [4] 437122 0
After patient reaches cycle 8 (10 months) or withdraws earlier
Secondary outcome [5] 437123 0
To assess health care professional's view of self-administration at home of daratumumab by participants with relapsed, refractory multiple myeloma
Timepoint [5] 437123 0
End of study, after the 50th evaluable patient reaches cycle 8 (10 months) or withdraws earlier

Eligibility
Key inclusion criteria
1. Males or females aged 18 years or older;
2. 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
3. Have relapsed following first or subsequent-line therapy for MM and require treatment;
Relapse defined as per International Myeloma Working Group definitions
4.Have an ECOG performance score of 0, 1 or 2;
5. Are considered suitable for treatment with daratumumab (in the opinion of the Investigator);
6. In the opinion of the Investigator, are considered suitable for home self-administration (or carer administration); and
7. Have provided written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have experienced NCI-CTCAE Grade 2 or worse peripheral neuropathy within the 14 days prior to enrolment;
2. Have any significant mobility issue that would preclude their ability to handle or deliver subcutaneous medications; or
3. Have significant cognitive impairment that, in the Investigator's opinion, would impede appropriate medication use.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
31/01/2027
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC

Funding & Sponsors
Funding source category [1] 316876 0
Other Collaborative groups
Name [1] 316876 0
Australasian Myeloma Research Consortium
Country [1] 316876 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Myeloma Research Consortium
Address
Country
Australia
Secondary sponsor category [1] 319120 0
None
Name [1] 319120 0
Address [1] 319120 0
Country [1] 319120 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315636 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 315636 0
Ethics committee country [1] 315636 0
Australia
Date submitted for ethics approval [1] 315636 0
01/10/2024
Approval date [1] 315636 0
15/11/2024
Ethics approval number [1] 315636 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135338 0
Dr Shafqat Inam
Address 135338 0
Alfred Health, 55 Commercial Road, MELBOURNE VIC 3004
Country 135338 0
Australia
Phone 135338 0
+61390763451
Fax 135338 0
Email 135338 0
s.inam@alfred.org.au
Contact person for public queries
Name 135339 0
Khoa Le
Address 135339 0
Alfred Health, Level 2 South Block, 55 Commercial Road Melbourne VIC 3004
Country 135339 0
Australia
Phone 135339 0
+61390767851
Fax 135339 0
Email 135339 0
amarc@alfred.org.au
Contact person for scientific queries
Name 135340 0
Dr. Shafqat Inam
Address 135340 0
Alfred Health, 55 Commercial Road, MELBOURNE VIC 3004
Country 135340 0
Australia
Phone 135340 0
+61390767851
Fax 135340 0
Email 135340 0
s.inam@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.