None listed
Conditions
Brief 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.
Interventions
Eligible patients will be randomised to received the either of the following:
- Velcade, Lenalidomide and Dexamethasone OR
- Velcade and Dexamethasone OR
- Lenalidomide and Dexamethasone
Lenalidomide will be administered at a dose of 10-25mg orally for Day 1 to 21 out of 28 Day cycle.
Velcade will be administered as subcutaneous injection at a dose of 1.0 - 1.3mg/m2 on Days 1, 8 and 15 out of 28 Day cycle. Dosage will be on body surface area and/or randmonised treatment arm.
Dexamethasone wi
Eligible patients will be randomised to received the either of the following: - Velcade, Lenalidomide and Dexamethasone OR - Velcade and Dexamethasone OR - Lenalidomide and Dexamethasone Lenalidomide will be administered at a dose of 10-25mg orally for Day 1 to 21 out of 28 Day cycle. Velcade will be administered as subcutaneous injection at a dose of 1.0 - 1.3mg/m2 on Days 1, 8 and 15 out of 28 Day cycle. Dosage will be on body surface area and/or randmonised treatment arm. Dexamethasone will be administered at a dose of 12-40mg orally on Days 1, 8 and 15 out of 28 Day cycle. Dosages of each treatment will be based on body surface area and/or randmonised treatment arm. All patients will continue on treatment until the either the development of progressive disease (PD), unacceptable toxicity, withdrawal of consent, or 6 years. Adherence is monitored through hospital drug administration records and tablet adherence through drug packet return.
Sponsors
Australasian Leukaemia & Lymphoma Group
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed