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Trial registered on ANZCTR


Registration number
ACTRN12624000027516
Ethics application status
Approved
Date submitted
28/11/2023
Date registered
12/01/2024
Date last updated
7/02/2024
Date data sharing statement initially provided
12/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Romosozumab for Patients with Multiple Myeloma with Skeletal Events on Zoledronic Acid: A Pilot Study
Scientific title
Romosozumab for Patients with Multiple Myeloma with Skeletal Events on Zoledronic Acid: A Pilot Study
Secondary ID [1] 311055 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple myeloma 332174 0
Condition category
Condition code
Cancer 328891 328891 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Romosozumab 210mg will be administered subcutaneously by a nurse every 28 days for 12 doses.
Intervention code [1] 327499 0
Treatment: Drugs
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336702 0
Safety of romosozumab in patients with multiple myeloma
Timepoint [1] 336702 0
Adverse events will be assessed at the end of each treatment cycles
Primary outcome [2] 336703 0
Effect of romosozumab treatment on bone turnover markers
Timepoint [2] 336703 0
0, 1, 3 and 12 months from the start of treatment
Secondary outcome [1] 429369 0
Bone mineral density
Timepoint [1] 429369 0
0 and 12 months from start of treatment
Secondary outcome [2] 429370 0
Skeletal related events
Timepoint [2] 429370 0
3, 6 and 12 months from the start of treatment
Secondary outcome [3] 429371 0
Progression free survival
Timepoint [3] 429371 0
Continuous assessment from the start of treatment until 12 months post-treatment commencement.

Eligibility
Key inclusion criteria
Males or females with multiple myeloma
Age 18 years or older.
Skeletal related event with at least 3 doses of anti-resorptive therapy
Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of myocardial infarction or stroke in prior 12 months
Women of child bearing potential
Active unstable cardiovascular function
Previous teriparatide or any parathyroid hormone (PTH) analogs
History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as Paget’s disease, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing’s disease, hyperprolactinemia and malabsorption syndrome
Vitamin D insufficiency, defined as 25 (OH) vitamin D levels < 50nmol/L. Vitamin D repletion will be permitted and subjects may be rescreened
Current hyper- or hypocalcemia
Current, uncontrolled hyper- or hypothyroidism
Current, uncontrolled hyper- or hypoparathyroidism,
History of dental extraction or other invasive dental work within 3 years, or who require invasive dental work within the next two years or history of osteonecrosis of the jaw
Life expectancy of less than 2 years.
Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/01/2024
Actual
Date of last participant enrolment
Anticipated
15/01/2026
Actual
Date of last data collection
Anticipated
15/01/2027
Actual
Sample size
Target
12
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25894 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 41728 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 315312 0
Charities/Societies/Foundations
Name [1] 315312 0
Tour De Cure
Country [1] 315312 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Sydney
Address
390 Victoria Street, Darlinghurst, NSW 2010
Country
Australia
Secondary sponsor category [1] 317363 0
None
Name [1] 317363 0
None
Address [1] 317363 0
Country [1] 317363 0
Other collaborator category [1] 282885 0
University
Name [1] 282885 0
Garvan Institute of Medical Research
Address [1] 282885 0
384 Victoria Street, Darlinghurst, NSW, 2010
Country [1] 282885 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314235 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 314235 0
97-105 Boundary Street, Darlinghurst NSW 2010
Ethics committee country [1] 314235 0
Australia
Date submitted for ethics approval [1] 314235 0
Approval date [1] 314235 0
20/07/2023
Ethics approval number [1] 314235 0
2023/ETH01092

Summary
Brief summary
Brief description of the study purpose
This study will examine the safety and efficacy of romosozumab (a drug to treat bone loss) in patients with multiple myeloma who have had a skeletal related event despite bisphosphonate therapy.

Who is it for?
You may be eligible to join this study if you are aged 18 years and older, have been diagnosed with multiple myeloma and had a skeletal related event despite previous treatment with bisphosphonate therapy

Study details
All participants who choose to enrol in this study will receive an Romosozumab subcutaneously every 28 days for 12 cycles. Patients will also receive calcium and vitamin D supplementation.
During and after completion of the treatment participants will be assessed for safety and effect of romosozumab. This will include monthly blood tests. A bone marrow biopsy will also be performed during screening for the study, following 12 months of treatment and at disease progression if this occurs during the study period. A CT skeletal survey will also be performed at screening and following 12 months of treatment and 12 months following completion of treatment.

It is hoped that this research project will demonstrate that romosozumab is safe to administer to patients with multiple myeloma and identify any potential bone modifying effects of this drug in these patients
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130890 0
Dr Georgia McCaughan
Address 130890 0
Kinghorn Cancer Centre, 370 Victoria Street, NSW, Darlinghurst 2010
Country 130890 0
Australia
Phone 130890 0
+61 293555656
Fax 130890 0
Email 130890 0
georgia.mccaughan@svha.org.au
Contact person for public queries
Name 130891 0
Dr Georgia McCaughan
Address 130891 0
Kinghorn Cancer Centre, 370 Victoria Street, Darlinghurst, NSW 2010
Country 130891 0
Australia
Phone 130891 0
+61 293555656
Fax 130891 0
Email 130891 0
georgia.mccaughan@svha.org.au
Contact person for scientific queries
Name 130892 0
Dr Georgia McCaughan
Address 130892 0
Kinghorn Cancer Centre, 370 Victoria Street, Darlinghurst, NSW 2010
Country 130892 0
Australia
Phone 130892 0
+61 293555656
Fax 130892 0
Email 130892 0
georgia.mccaughan@svha.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.