None listed
Conditions
Brief summary
This study proposes to explore the safety and efficacy of lenalidomide consolidation post allogeneic stem cell transplant in patients with high risk multiple myeloma who fail to achieve stringent complete response. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a diagnosis of multiple myeloma for which you plan to undergo stem cell transplantation. Study details All participants in this study will commence treatment with Lenalidomide 180 days after stem cell transplantation. Lenalidomide is a chemotherapy drug which is taken orally at an initial dose of 10mg daily for 21 of 28 days (1 cycle), increasing to 15mg for subsequent treatment cycles. This will be taken in combination with weekly oral dexamethasone for the first 2 cycles. Treatment will continue until any of the following occurs: a. Unacceptable toxicity/adverse event that may cause severe or permanent harm which rule out continuation of the study drug b. Relapse/progressive disease and alternative myeloma treatment is required c. Death d. The study may also be terminated early if safety concerns emerge with this treatment Participants will be regularly monitored until relapse or end of treatment in order to evaluate the safety and tolerability of the treatment, as well as disease response.
Interventions
Treatment commences approx. 180 days post stem cell transplant.
Lenalidomide will be dosed at 10mg orally daily for 21 of 28 days for cycle #1 (28 day cycle) and escalated to 15mg daily for 21 of 28 days for cycle #2 onwards. Cycles will continue to a maximum of 10, or until disease progression, unacceptable toxicity or death.
Dexamethasone will be given for first two cycles only at a dose of 40mg orally weekly in cycle#1 and 20mg weekly in cycle #2.
Sponsors
Alfred Health
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 No maximum
Healthy volunteers
No
Inclusion criteria
Pre allo-SCT 1. Age >18 years of age 2. Diagnosis of multiple myeloma as per IMWG criteria: a. Clonal plasma cells greater than 10% b. Presence of serum and/or urinary monoclonal protein (except in patients with true non-secretory multiple myeloma), and c. Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically i.[C] Hypercalcaemia: serum calcium greater than or equal to 11.5mg/100ml or ii.[R] Renal insufficiency: serum creatinine > 173 micro mol/l or iii.[A] Anaemia: normocytic, normochromic with a haemoglobin value of >20g/l below the lower limit of normal or a haemoglobin value <100g/l or iv.[B] Bone lesions: lytic lesions, severe osteopenia or pathologic fractures. 3. Plan to undergo tandem autologous and allogeneic SCT 4. No known contraindication to study drugs Post allo-SCT - 5. ECOG 0-2 6. Undergone tandem autologous and allogeneic SCT 7. Reached day 180 post allogeneic SCT AND be off all immunosuppression (including systemic steroids) for >2 weeks AND have failed to achieve stringent complete response. 8. Adequate renal function (<2 x institutional upper limit of normal) 9. Adequate liver function (<3 x institutional upper limit of normal) 10. Platelet count > 75 x 10^9, absolute neutrophils count > 1.5 x 10^9 11. Patient has voluntarily agreed and has given written informed consent 12. All women of childbearing potential (WOCBP)** must agree to have two negative pregnancy tests (the 1st pregnancy test must be done 10-14 days and 2nd must be done within 24 hours of commencing lenalidomide) before commencing lenalidomide and use two reliable methods of contraception simultaneously or to practice complete abstinence from any sexual contact during the following time periods related to this study: 1) for at least 28 days before starting study; 2) while participating in the study; 3) dose interruptions; and 4) for at least 28 days after study treatment discontinuation. The two methods of reliable contraception must include one highly effective method and one additional effective method. All male participants must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy
Exclusion criteria
Post allo-SCT 1. Current active graft versus host disease (acute or chronic) requiring immunosuppression 2. Prior acute graft versus host disease grade II-IV 3. Received donor lymphocyte infusion (DLI) within 8 weeks of commencing study drug 4. Uncontrolled medical illness or infections 5. Relapsed/progressive myeloma
Outcome results
None listed