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

  1. 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.
  2. 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.
  3. 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).
  4. Patients with a HLA identical related or ten/ten antigen (A,B,C,DQ,DR) matched unrelated donor.
  5. Cardiac ejection fraction > 40%.
  6. Creatinine clearance >50 ml/min.
  7. Liver function (AST or ALT) < 2.5 x upper limit of normal.
  8. 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.
  9. Patients willing and able to comply with the protocol for the duration of the study.
  10. 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.
  11. Agree not to share study drug with another person and to return all unused study drug to the investigator or pharmacist.

Exclusion criteria

  1. Patients with allergies or contraindications to receiving fludarabine, Lenalidomide, ciclosporin or ATG.
  2. Pregnant or lactating women.
  3. Adults of reproductive potential not willing to comply with the Lenalidomide Risk Minimisation Plan (see below for details).
  4. Patients with organ allografts.
  5. Any co-morbidity that, in the investigators opinion, would affect the patient’s participation in this study.
  6. 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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