PADIMAC

• Research type

  Research Study

• Full title

  Phase II study of Bortezomib, Adriamycin and Dexamethasone (PAD) therapy for previously untreated patients with multiple myeloma: Impact of minimal residual disease (MRD) in patients with deferred ASCT (PADIMAC)

• IRAS ID

  57841

• Contact name

  Kwee Yong

• Eudract number

  2010-021598-35

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Multiple Myeloma is a cancer of the bone marrow and, for those patients that are fit enough, the disease is usually treated with chemotherapy followed by a stem cell transplant using the patient??s own stem cells (autograft or Autologous Stem Cell Transplant). Unfortunately almost all patients will relapse (i.e. the disease will come back) at some point following this treatment. After relapse there are a number of treatment options but eventually the disease will become resistant to further therapy. Retrospective studies suggest that patients who achieve a complete remission as a result of chemotherapy will have a long remission period even without a stem cell transplant. For such patients the benefit from proceeding straight onto a stem cell transplant is questionable. Instead, it may be better to save this treatment option until such a time as when their disease relapses. This is because research has shown that stem cell transplantation is an effective treatment option after relapse. Patients on this study will be younger patients who are fit enough for a stem cell transplant. They will be treated with a bortezomib-containing regimen that is given intravenously. Bortezomib is a new and effective treatment for patients with myeloma, producing response rates that are significantly higher than traditional regimens, including higher complete response rates. The purpose of this study is (1) to confirm the high response rate to a bortezomib-containing regimen, and (2) to confirm that patients who have achieved a complete response to initial chemotherapy can have a long remission when they do not proceed immediately to a stem cell transplant. These patients will have their stem cells harvested so that they can still have a transplant when they relapse. The study will be conducted at several centres in England and Northern Ireland.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  10/H0502/58

• Date of REC Opinion

  26 Aug 2010

• REC opinion

  Favourable Opinion