Post Transplant Lenalidomide for Multiple Myeloma (Version 1)

• Research type

  Research Study

• Full title

  Phase II Study of the Adjunctive Use of Lenalidomide in Patients Undergoing Reduced Intensity Conditioning Allogeneic Transplantation for Multiple Myeloma

• IRAS ID

  6528

• Contact name

  Mark Cook

• Sponsor organisation

  University Hospital Birmingham NHS Foundation Trust

• Eudract number

  2009-012033-30

• ISRCTN Number

  Pending

• Research summary

  Allogeneic Stem Cell Transplant(SCT) remains the only curative option for multiple myeloma (MM). However, conventional (myeloablative) transplants remain associated with a substantial transplant related mortality which compromises effectiveness in younger patients and precludes their use entirely in patients over the age of 55 years. The recent demonstration that the use of reduced intensity conditioning (RIC) regimens substantially reduces the toxicity of allografting, whilst permitting durable donor stem cell engraftment, has raised the hope of extending this procedure to many patients who would currently not be considered for transplantation.Recent data has demonstrated that graft versus host disease (GVHD) can be a major cause of morbidity and mortality even when using a reduced intensity regimen. However, this can be significantly reduced by the depletion of donor T cells (TCD) from the stem cell inoculum. In the setting of a myeloablative conditioning regimen, TCD is associated with a high relapse rate and it is therefore likely that the success of reduced intensity transplants will be dependent on additional donor lymphocyte infusion (DLI) after transplantation.Donor lymphocytes can be safely administered in patients who relapse late after transplantation but are probably more effective as a prophylactic regimen. Routine use of DLI early after transplant is generally avoided; as the risk of GVHD increases the sooner DLI is administered after transplant. In the context of myeloma, the strategy of delayed DLI (at one year) reduces the risk of GVHD. Consequently, an independent anti-myeloma strategy early after transplantation is required to allow sufficient delay before DLI can be safely administered. The tolerability and remarkable activity of lenalidomide against myeloma makes it an excellent candidate to be used in an adjunctive role early after a reduced intensity regimen transplant prior to later institution of DLI, to suppress the growth and rapid recovery of a residual myeloma cell population.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  10/H1208/49

• Date of REC Opinion

  12 Nov 2010

• REC opinion

  Further Information Favourable Opinion