None listed
Conditions
Brief summary
A post stem cell transplant maintenance study with lenalidomide in combination with alternate day prednisolone. All patients will be registered prior to stem cell transplant, be planned for single high dose Melphalan-conditioned stem cell transplant and have no evidence of disease progression at re-staging 6 weeks post transplant. Oral lenalidomde will commence at a dose of 10mg daily. After 2 months following commencement, escalation or reduction of lenalidomide can be made at the discretion of the treating doctor, depending on tolerance or intolerance of the treatment. Alternate day prednisolone will commence at a dose of 50mg on alternate days with lenalidomide. No dose escalation of prednisolone is planned. Dose reductions are permitted to manage any side effects according to the study protocol. This treatment will continue until unacceptable side effects or disease relapse/progressive disease. Pre transplant, all patients will undergo disease restaging with blood tests and bone marrow aspirate. Bloods for serum storage for DNA analysis will be obtained. 6 weeks post transplant patients with adequate recovery will undergo rstaging of their disease with blood testing and bone marrow, to confirm continuing disease response. Patients with disease progression evident on re-staging will not be eligible for treatment on this study. On study, all patients will continue to be evaluated every 4 weeks with repeat blood testsfor response and monitoring until disease progression.
Interventions
Lenalidomide will be commenced orally at a dose of 10mg daily for 6 weeks following stem cell transplant. If this dose is well tolerated it may be increased at the discretion of the attending haematologist 2 months following commencement. Converseley, in patients with suspected lenalidomide toxicity, dose reductions in 5mg steps will be allowed for management of myelo-suppression. Dose re-escalation of lenalidomide at the discretion of the attending haematologist will be allowed subsequently whe
Lenalidomide will be commenced orally at a dose of 10mg daily for 6 weeks following stem cell transplant. If this dose is well tolerated it may be increased at the discretion of the attending haematologist 2 months following commencement. Converseley, in patients with suspected lenalidomide toxicity, dose reductions in 5mg steps will be allowed for management of myelo-suppression. Dose re-escalation of lenalidomide at the discretion of the attending haematologist will be allowed subsequently where toxicity abates. Alternate-day prednisolone will start at a dose of 50mg. No escalation of prednisolone will be allowed to manage toxicities. Patients intolerantof prednisolone can continue on single agent lenalidomide.
Sponsors
Malignant haematology and stem cell transplant Service
Study design
Allocation
Non-randomised trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
At registration pre-ASCT -Age over 17 years -Diagnosis of multiple myeloma as per IMWG criteria -No more than 12 months total prior standard- dose chemotherapy. -No previous high-dose chemotherapy or autologous transplantation procedure. -ECOG performance status 0, 1, or 2. -Normal liver and kidney function (within 2 x the institutional upper limit of normal). -No contraindication to the use of any of the study drugs -Greater than or equal to 2.0 x 106/kg CD34+ stem cells available for infusion. -Written informed consent. To commence RAP post-ASCT -Have reached Day 42 post-ASCT with evidence of haemopoietic reconstitution (neutrophils > 1.5 x 109/litre and platelets unsupported >50 x 109/litre). -No evidence of progressive myeloma. -All women of childbearing potential must agree to have a negative pregnancy test in the 24hrs before commencing lenalidomide, take adequate precautions to prevent pregnancy, not plan on conceiving children during or within 6 months following lenalidomide. -All male participants must use barrier contraception during and for 4 weeks after completion of lenalidomide. -No contraindication to prednisolone or lenalidomide -Have an ECOG performance status of 0 – 2.
Exclusion criteria
-Patients with monoclonal gammopathy of uncertain significance. -Patients with progressive MM pre or post stem cell transplant. -Patients whose general condition makes them unsuitable for intensive treatment e.g. significant cardiac or pulmonary disease. -Active infections or other illnesses that would preclude conditioning chemotherapy or maintenance therapy administration or patient compliance. -Pregnant or lactating women.
Outcome results
None listed