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The Clinical research facility is part of the NIHR and is funded by the Department of Health
LenaRIC
Trial Overview
LenaRIC – Phase II study of the adjunctive use of Lenalidomide in patients undergoing reduced intensity conditioning allogenic transplantation for multiple myeloma.
Inclusion criteria
- Multiple myeloma subjects who have received a high dose melphalan conditioned autologous transplant in the preceding 180 days and who are in CR1/2 or VGPR1/2 as defined by International uniform response criteria for Myeloma, 2006.
- Patients >18 years and ≤70 years in whom allogeneic transplantation using a reduced intensity conditioning regimen is not contra-indicated but who are not suitable for conventional allograft.
- ECOG status ≤2 or an ECOG status of 3 if the reason for a status of 3 is due exclusively to multiple myeloma (e.g. pathological fracture).
- Patients with a HLA identical related or ten/ten antigen (A,B,C,DQ,DR) matched unrelated donor.
- Cardiac ejection fraction > 40%.
- Creatinine clearance >50 ml/min.
- Liver function (AST or ALT) < 2.5 x upper limit of normal.
- Patients able to give written informed consent prior to allogeneic transplant, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
- Patients willing and able to comply with the protocol for the duration of the study.
- Agree to abstain from donating blood (and semen in male subjects) while taking study drug therapy and for 28 days following discontinuation of study drug therapy.
- Agree not to share study drug with another person and to return all unused study drug to the investigator or pharmacist.
Exclusion criteria
- Patients with allergies or contraindications to receiving fludarabine, Lenalidomide, ciclosporin or ATG.
- Pregnant or lactating women.
- Adults of reproductive potential not willing to comply with the Lenalidomide Risk Minimisation Plan (see below for details).
- Patients with organ allografts.
- Any co-morbidity that, in the investigators opinion, would affect the patient’s participation in this study.
- Patients who have taken any other investigational medical product within 4 weeks of starting conditioning therapy.
Research Nurse
Anne Ewing
Tel: 0113 2067404
E-mail: Anne.Ewing@leedsth.nhs.uk
Trial Coordinator
Laura Searle
Tel: l.e.j.searle@bham.ac.uk
E-mail: lenaric@trials.bham.ac.uk
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