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Clinical Trial Details

A phase I/II single arm study of combination Belantamab Mafodotin, Carfilzomib, Dexamethasone in patients with early relapsed multiple myeloma

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Trial Information

Broad Health Condition Cancer

Specific Health ConditionMyeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,SA,VIC

Hospital
The Alfred - Melbourne
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Barwon Health - Geelong Hospital campus - Geelong
The Royal Adelaide Hospital - Adelaide
Calvary Mater Newcastle - Waratah
Concord Repatriation Hospital - Concord
Border Medical Oncology - Albury
Flinders Medical Centre - Bedford Park
The Townsville Hospital - Douglas
Royal Brisbane & Womens Hospital - Herston


Postcode
3004 - Melbourne
3065 - Fitzroy
3220 - Geelong
5000 - Adelaide
2298 - Waratah
2139 - Concord
2640 - Albury
5042 - Bedford Park
4814 - Douglas
4029 - Herston

Anticipated date of first participant enrolment31/12/2020

Anticipated date of last participant enrolment31/12/2020

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Further information iconApproved

Trial summary

The study aims to determine the efficacy of combination therapy with Carfilzomib and Dexamethasone and Belantamab mafodotin (BelaMaf-Kd) for patients with relapsed refractory multiple myeloma.  Belantamab mafodotin is a new drug which has not been approved for use by the Therapeutic Goods Administration and so this combination is considered an experimental treatment.

Who is it for?
You may be eligible to participate in this trial if you are aged 18 years or over, and have received between 1 to 3 prior lines of therapy for multiple myeloma but have not undergone allogeneic stem cell transplantation.

Study Details
Eligible participants will receive 6 cycles of combination BelaMafKd with treatment given over a 28 day cycle as tolerated. Belantamab mafodotin and Carfilzomib will be delivered by IV infusion on days 1 and 8 and days 1, 8 and 15 respectively. Dexamethasone will be given orally weekly. 

Participants will be required to have blood samples taken and medical reviews (including ophthalmic examination) at the beginning of each cycle. An ultrasound test of cardiac function will be performed at screening and within 2 weeks of completion of cycle 6. A bone marrow biopsy will be performed at screening, at cycle 6 and to confirm a complete response or disease progression. These assessments will enable researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma. 
Study treatments will be halted if participants show disease progression, unacceptable toxicity, or upon withdrawal of consent.
A final medical assessment and ophthalmic exam will be performed at end of treatment, with follow up to continue every 12 weeks until one year after the final cycle of treatment.

Follow up assessments will continue every 12 weeks until one year after the final cycle of treatment.

It is hoped that the findings of this trial will establish the benefits of Belantamab mafodotin in combination with Carfilzomib and Dexamethasone for the treatment of patients with early relapsed multiple myeloma.
Eligibility

Key inclusion criteria

Participants must have: 
1. confirmed multiple myeloma as defined by the International Myeloma Working Group criteria
2.  at least 1 and no more than 3 prior lines of therapy
3. measurable disease defined as at least one of:
a. Serum M-protein concentration of 5g/L or greater
b. Urine M-protein excretion of 200mg/24hr or greater OR
c. Serum free light chain (FLC) assay: involved FLC level  of 100mg/L or greater and an abnormal serum free light chain ration (<0.26 or >1.65)
4. Adequate organ system function:
a. Haematological: Absolute neutrophil count of 1.0x109/L or greater, Haemoglobin of80g/L or greater, Platelet count of 50x109/L or greater
b. Hepatic: ALT < 2.5xULN and Bilirubin < 1.5xULN
c. Renal: eGFR > 20ml/min
d. Cardiac: LVEF > 45%

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Participants must not have had/be:
1. systemic anti-myeloma therapy within 14 days with the exception of corticosteroids equivalent to dexamethasone 160mg or greater within last 4 weeks
2. prior treatment with a monoclonal Antibody within 30 days of receiving first dose of study drugs
3. prior allogeneic stem cell transplant.
4. evidence of cardiovascular risk: QTc interval of 470msec or greater; uncontrolled arrhythmias; history of myocardial infarction or acute coronary syndrome within last 6 months; class II or IV heart failure defined by New York Heart Association functional classification system.
5. Pregnant or lactating females
6. Active infection requiring treatment
7. Known HIV infection
8. Hepatitis B surface Antigen (HbsAg) or Hepatitis B core Antibody (HBcAb) positivity 
Positive hepatitis C antibody or positive hepatitis C RNA at screening or within 3 months prior to first dose of study treatment. (NOTE: participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if confirmatory negative hepatitis C RNA is obtained.)
9. Current corneal disease except for mild punctate keratopathy.
10. Known immediate or delayed hypersensitivity or unacceptable adverse effects from previous proteasome inhibitors.
11. Ongoing grade 2 or higher peripheral neuropathy
12. Known immediate or delayed hypersensitivity reaction to drugs chemically related to Belantamab Mafodotin
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australasian Myeloma Research Consortium
Primary Sponsor Address: Australasian Myeloma Research Consortium Alfred Hospital 55 Commercial Rd Melbourne VIC 3004
Primary Sponsor Country: Australia

Trial IDACTRN12620000490976

Contact person for information and recruitmentMr
Khoa Le
Alfred Hospital 55 Commercial Rd Melbourne VIC 3004
+61390767851

Further information iconkhoa.le@alfred.org.au
Australia