None listed
Conditions
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.
Interventions
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 b
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
Sponsors
Dr Stephen Kenneth O'Mara
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed