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Clinical Trial Details

Frailty-stratified, randomised controlled Bayesian adaptive trial of bortezomib versus lenalidomide in transplant-ineligible myeloma (TI-NDMM) – the FRAIL-M study

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Trial Information

Broad Health Condition Cancer

Specific Health ConditionMyeloma

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,NT,QLD,SA,TAS,VIC

Hospital
The Alfred - Melbourne
St George Hospital - Kogarah
Calvary Mater Newcastle - Waratah
The Royal Adelaide Hospital - Adelaide
Royal Hobart Hospital - Hobart
Sunshine Hospital - St Albans
Princess Alexandra Hospital - Woolloongabba
Sunshine Coast University Hospital - Birtinya
Concord Repatriation Hospital - Concord
Tamworth Rural Referral Hospital - Tamworth
Western Hospital - Footscray - Footscray
Nepean Hospital - Kingswood
Royal Darwin Hospital - Tiwi
The Townsville Hospital - Douglas
The Queen Elizabeth Hospital - Woodville
Toowoomba Hospital - Toowoomba


Postcode
3004 - Melbourne
2217 - Kogarah
2298 - Waratah
5000 - Adelaide
7000 - Hobart
3021 - St Albans
4102 - Woolloongabba
4575 - Birtinya
2139 - Concord
2340 - Tamworth
3011 - Footscray
2747 - Kingswood
0810 - Tiwi
4814 - Douglas
5011 - Woodville
4350 - Toowoomba


Trial location outside Australia
New ZealandDunedin Hospital - Southern DHB
New ZealandMiddlemore Hospital, Auckland

Anticipated date of first participant enrolment15/11/2019

Anticipated date of last participant enrolment15/11/2019

Phase of TrialPhase 1 / Phase 2

Has the study received ethics approval?Further information iconApproved

Trial summary

The study utilises the infrastructure of a national clinical registry (Australian and New Zealand Myeloma and Related Diseases Registry) to enable identification of patients, efficient data collection, long-term follow-up beyond the trial and comparison with non-trial patients to assess study generalisability. The primary purpose of this trial is to assess appropriate treatment approach newly diagnosed with multiple myeloma with respect to frailty assessment.

Who is it for?
You may be eligible to participate in this trial if you are aged 18 years or over, have been newly diagnosed with multiple myeloma and are a candidate for chemotherapy but not for autologous stem cell transplant.

Study details
Eligible participants will be treated with their allocated treatment regimen (bortezomib or lenalidomide) through randmonisation. All patients will continue on treatment until the either the development of progressive disease (PD), unacceptable toxicity or withdrawal of consent.
Participants will be required to have blood samples taken at the beginning of each cycle along with a medical exam in order for researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma.
It is hoped that the findings of this trial will establish the most appropriate treatment approach in the context of the Australian re-imbursement environment.
Eligibility

Key inclusion criteria

1.	Male and Female patients, equal to or greater 18 years of age.

2.	Symptomatic NDMM as per IMWG criteria

3.	Measurable disease as defined by a paraprotein 5g/L and/or an involved light chain isotype 100mg/l with an abnormal kappa:lambda ratio.

4.	Not eligible for high-dose melphalan conditioned autologous stem cell transplantation (ASCT) due to age and/or co-morbidities.

5.	No contraindication to the use of any of the study drugs.

6.	Adequate liver function (total bilirubin less than 2.0x ULN, ALT less than 5.0x ULN) unless considered secondary to MM.

7.	Adequate haematological parameters - Hb equal to or greater 80g/L (RBC transfusions as per institutional protocol are allowed); absolute neutrophil count equal to or greater 1.0 x 109/L; and, platelet count equal to or greater 50 x 109/L (equal to or greater 30 x 109/L if MM involvement in the marrow is greater than 50%) without platelet transfusion within 7 days of the screening platelet count.

8.	Has provided written informed consent.

9.	Women of childbearing potential must have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/mL performed before, during and after treatment. 

10.	Women of childbearing potential and male subjects who are sexually active with WOCP must agree to use 2 highly effective methods of contraception during the study and for 30 days following the last dose of study treatment including a male condom. 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	Prior treatment for MM apart from localised radiotherapy and/or a short course of steroids (dexamethasone 160mg or equivalent) for emergency management of MM related symptoms.

2.	Patients who have had myocardial infarction within 3 months prior to enrolment, or NYHA (New York Hospital Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.

3.	Creatinine clearance <30ml/min that persists after correction of recognisable reversible factors e.g. hypercalcaemia, dehydration, sepsis etc.

4.	Any other serious or uncontrolled medical or psychiatric illness that could, in the investigators opinion, potentially interfere with the completion of treatment according to this protocol.

5.	Known ongoing or active systemic infection, active hepatitis B or C infection, or known human immunodeficiency (HIV) positivity.

6.	Women who are pregnant or lactating. Women of child-bearing potential must have a negative urine pregnancy test at Screening.

7.	Patient (to whom it is relevant) who is unable or unwilling to meet the requirements of the lenalidomide pregnancy prevention program.

8.	Active malignancy with the exception of any of the following: 
a.	Adequately treated basal cell carcinoma, squamous cell carcinoma or in situ cervical cancer.
b.	Adequately treated stage 1 cancer from which the subject is currently in remission from and has been in remission for > 2 years.
c.	Stage 1 prostate cancer that does not require treatment.
d.	Any other cancer from which the subject has been disease-free for > 2 years.

9.	Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial.
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australasian Leukaemia & Lymphoma Group
Primary Sponsor Address: 35 Elizabeth St, Richmond VIC 3121
Primary Sponsor Country: Australia

Trial IDACTRN12619001199101

Contact person for information and recruitmentMiss
Flora Yuen
Alfred Hospital 55 Commercial Road Melbourne VIC 3004
+61 3 9076 5407

Further information iconflora.yuen@alfred.org.au
Australia