Clinical Trial: A Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With Primary (AL) Amyloidosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective Single Center Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With AL Amyloidosis

Brief Summary: The treatment with oral melphalan and prednisone has been recommended as standard treatment of AL amyloidosis but the results are rather disappointing. Another therapeutic option is pulsed high-dose dexamethasone + melphalan (Mel-Dex) with more encouraging results regarding the achievement of a faster disease response and higher rates of haematological remission. In the last 5 - 10 years, promising treatment outcomes after therapy with high-dose melphalan and autologous stem cell support have been reported by several groups but only highly selected patients are eligible for this treatment. Lenalidomide has been shown to be effective in phase II and III trials in MM patients. Because of the relationship to MM, Lenalidomide is a promising therapeutic option also for patients with AL amyloidosis. The addition of Lenalidomide to Mel-Dex could improve rate of complete response (CR) and organ response in patients not eligible for or refused high-dose chemotherapy.

Detailed Summary:
Sponsor: Heidelberg University

Current Primary Outcome: Complete response (CR) rate [ Time Frame: 6 months: after 6 cycles of L-Mel-Dex ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of hematological response (CR and PR) [ Time Frame: 6 months ]
  • Organ response rate [ Time Frame: 3 months after discontinuation of L-Mel_Dex (maximum: 9 months) ]
  • Correlation of cytogenetic aberrations and gene expression profiling (GEP) results with best hematological response to treatment [ Time Frame: 6 months ]
  • Retrospective comparison with a historical control group treated with Mel-Dex in our institution [ Time Frame: 01.04.2012 ]
  • Toxicity (hematological and non-hematological) [ Time Frame: 6 months ]


Original Secondary Outcome:

  • Rate of hematological response (CR and PR) [ Time Frame: 6 months ]
  • Organ response rate [ Time Frame: 3 months after discontinuation of L-Mel_Dex (maximum: 9 months) ]
  • Correlation of cytogenetic aberrations and GEP results with best hematological response to treatment [ Time Frame: 6 months ]
  • Retrospective comparison with a historical control group treated with Mel-Dex in our institution [ Time Frame: 01.04.2012 ]
  • Toxicity (hematological and non-hematological) [ Time Frame: 6 months ]


Information By: Heidelberg University

Dates:
Date Received: April 15, 2009
Date Started: April 2009
Date Completion:
Last Updated: November 21, 2013
Last Verified: November 2013