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Trial registered on ANZCTR


Registration number
ACTRN12617001516370
Ethics application status
Not required
Date submitted
30/08/2016
Date registered
31/10/2017
Date last updated
31/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
MOM trial. MOntelukast Myeloma A pilot study to determine whether Montelukast added to standard Chemotherapy improves response in patients who have failed standard Chemotherapy for Multiple Myeloma.
Scientific title
A Pilot study to determine whether Montelukast added to CyBorD (Bortezomib/Cyclophosphamide/Dexamethasone) induces responses in patients not responding to CyBorD chemotherapy.
Secondary ID [1] 289985 0
Nil known
Universal Trial Number (UTN)
u1111-1186-7037
Trial acronym
MoM (MOntelukast in Myeloma)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 299989 0
Condition category
Condition code
Cancer 299882 299882 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be Montelukast given at a dose of 20mg or 40mg per day orally with Gemfibrozil 600mg twice daily orally. The dose of Montelukast will start at 20mg and increase to 40mg if there is no toxicity at the 7 day review. The increased dose will be given until seven days after all subsequent chemotherapy cycles are administered. The study drugs will be given daily without interruption until seven days after the last chemotherapy agent is administered.. The dose can be reduced back to 20 mg a day if any significant side effects are observed.
Chemotherapy (CyBorD.) Montelukast and Gemfibrozil is given from day 1 until day 28 of each cycle and 7 days after all chemotherapy planned is administered. The dose is increased from 20mg to 40mg if there is no toxicity at 7 days. It can be reduced back to 20mg if any subsequent toxicity is observed.
28 day cycle in all patients.
Bortezomib 1.3mg^m2 subcutaneous injection on day 1,7,15,21 of each 21 day cycle. for two cycles
Cyclophosphamide 100mg given orally daily throughout treatment period for two cycles
Dexamethasone 20mg orally is given on d1,d7,d14,d21 of each 28 day cycle for two cycles
Intervention code [1] 295680 0
Treatment: Drugs
Comparator / control treatment
The patient will act as there own control. The response will be compared to the patients previous historical lack of response to standard CyBorD chemotherapy at the end of two cycles.(

This will enable analysis using a paired t test.
Control group
Active

Outcomes
Primary outcome [1] 299360 0
Change in either Serum M protein or serum light chain after two cycles of treatment with Montelukast and Gemfibrozil by analysis of pathology results.

Timepoint [1] 299360 0
2 cycles of therapy
Primary outcome [2] 303717 0
Unexpected side effects will be determined by WHO criteria.
This will be assessed weekly by history and examination.
Blood tests will be performed and reviewed weekly for unexpected Renal, Hepatic or Haematological toxicity
Timepoint [2] 303717 0
At the conclusion of each cycle of administration.
Secondary outcome [1] 326923 0
Survival
Timepoint [1] 326923 0
12 months from treatment by analysis of patient records.

Eligibility
Key inclusion criteria
Patients with progressive disease after at least 8 weeks of treatment with a standard accepted Multiple Myeloma regimen, who have exhausted all other therapies. Patients will have to have response data for their previous treatment with Velcade/Cyclophosphamide/Dexamethasone.

Patients who show less than partial response at 8 weeks of Bortezomib/Cyclophosphamide/Dexamethasone chemotherapy. This is 20% of patients.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient showing at least a partial response to last treatment regimen for multiple myeloma. Pregnancy.
ECOG status 3 or 4
Patients unable to give informed consent.

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
Patients results will be compared to their previous response/results to same chemotherapy regimen. The analysis will be with paired t-test for the values of paraprotein, light chain and percentage bone marrow involvement. Due to the design of the study only a small number of patients will be needed to demonstrate efficacy. If their is no demonstrable improvement in response after analysis of these 6 patients then the treatment would have deemed to fai and no other research will take place.
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Paraprotein, serum light chain and will be converted to a percentage of pre treatment level. it will then be analysed using paired t-test with the patients previous results acting as control.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6577 0
Tamara Private Hospital - Tamworth
Recruitment postcode(s) [1] 14081 0
2350 - Armidale
Recruitment postcode(s) [2] 14184 0
2340 - Tamworth

Funding & Sponsors
Funding source category [1] 294356 0
Self funded/Unfunded
Name [1] 294356 0
Dr Stephen O'Mara
Address [1] 294356 0
40 Piper st
Tamworth NSW 2340
Country [1] 294356 0
Australia
Primary sponsor type
Individual
Name
Dr Stephen Kenneth O'Mara
Address
Private practice
New England Northwest Haematology.
40 Piper st
Tamworth, NSW 2340
Country
Australia
Secondary sponsor category [1] 293195 0
None
Name [1] 293195 0
Dr Stephen O'Mara
Address [1] 293195 0
Private Practice
Country [1] 293195 0
Australia

Ethics approval
Ethics application status
Not required

Summary
Brief summary
This pilot study aims to test whether Montelukast and Gemfibrozil when added to CyBorD chemotherapy (Bortezomib Cyclophosphamide and Dexamethasone 28 day cycle) induces responses in patients not responding to this chemotherapy.

Who is it for?
You may be eligible to join this study if you are aged 18-80 years with progressive multiple myeloma after at least 8 weeks (two cycles) of treatment with a standard Bortezomib/Cyclophosphamide/Dexamethasone chemotherapy.

Study details
A total of 6 patients will be enrolled prior to a decision to expand or shut down the trial, depending on toxicity and response. Participants will receive further two cycles of CyBorD chemotherapy regimen with the addition of Montelukast. and Gemfibrozil..

Patients will be able to continue Montelukast and Gemfibrozil following completion if a response is observed depending on side effects

The hypothesis is that Montelukast which is an extremely well tolerated medication used to treat Asthma in all age groups, will sensitize patient’s tumour to chemotherapy which was previously shown to be resistant to the same therapy.
Trial website
Trial related presentations / publications
Public notes
Email confirmation by HNEhealth Ethics that due to the nature of the study in which non toxic off label use of medications was being used that it would be considered a case series. 30/08/2016. A copy of this correspondence will not be attached due to personal comments. This trial may be expanded following the review of data in December 2017.
Attachments [1] 2124 2124 0 0

Contacts
Principal investigator
Name 68426 0
Dr Stephen O'Mara
Address 68426 0
Tamara Consulting rooms.
40 Piper st
Tamworth NSW 2340
Country 68426 0
Australia
Phone 68426 0
+61 2 67663299
Fax 68426 0
Email 68426 0
somara@tpg.com.au
Contact person for public queries
Name 68427 0
Dr Stephen O'Mara
Address 68427 0
Tamara Consulting rooms
40 Piper st
Tamworth 2340
Country 68427 0
Australia
Phone 68427 0
+61 2 67663299
Fax 68427 0
Email 68427 0
somara@tpg.com.au
Contact person for scientific queries
Name 68428 0
Dr Stephen O'Mara
Address 68428 0
Tamara Consulting rooms
40 Piper st.
Tamworth 2340
Country 68428 0
Australia
Phone 68428 0
+61 2 67663299
Fax 68428 0
Email 68428 0
somara@tpg.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary