Clinical Trial: Lendexal in Patients With Primary Systemic Amyloidosis (AL) Newly Diagnosed

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

Official Title: A Multicentric, Phase II Trial of Lenalidomide, Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Amyloidosis (AL) Newly Diagnosed, Not Candidates for H

Brief Summary:

Primary outcome measure:

- Hematologic response rate to the association of Lenalidomide, Cyclophosphamide and Dexamethasone.

Secondary outcome measures:

  • Organ response rate.
  • Predictors of response (cardiac biomarkers, serum free light chains).
  • Toxicity
  • Safety (type, frequency, severity and relationship of adverse events to the study drug).
  • Duration of response.
  • Time to progression.
  • Overall survival

Detailed Summary:

It is a multicenter, single arm treatment, phase II study of the combination in one treatment arm with Lenalidomide, Cyclophosphamide and Dexamethasone.

Subjects who qualify for participation will receive lenalidomide plus dexamethasone and cyclophosphamide in 4-week cycles. Subjects will be seen (study visits) every 2 weeks for the first 3 cycles of therapy and monthly thereafter.

Cycles of lenalidomide/dexamethasone/cyclophosphamide will consists of lenalidomide 15 mg by mouth for 21 days followed by 7 days rest and 300 mg/m2 of cyclophosphamide on days 1 and 8 plus oral dexamethasone 20 mg/day on days 1-4 and 9-12 given at 4-week intervals. Patients will be treated with 6 cycles of therapy with the option to continue beyond as long there is evidence of response. In this case the dose of lenalidomide will be the same and the dose of the dexamethasone will be administered only on days 1 to 4 of each cycle and the dose of cyclophosphamide only day 1 during 6 cycles. After 12 cycles if the patients remaining in response, will be treated with 10 mg/day, cyclophosphamide day 1, and dexamethasone will be administered on days 1 to 4 of each cycle.

For the first 3 cycles, patients will be followed for adverse events with hematologic control every 2 weeks and monthly thereafter. Patients will be required to have a blood work-up including total serum protein and serum protein electrophoresis, urine protein studies and a clinical visit before each cycle. Organ involvement will be assessed every 4 cycles during the first year of therapy. Hematologic response will be assessed every 3 months and organ response every 6 months after the first year of treatment.

Treatment modifications will be based on adverse events graded according to th
Sponsor: PETHEMA Foundation

Current Primary Outcome: Hematologic response rate to the association of Lenalidomide, Cyclophosphamide and Dexamethasone [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Organ response rate [ Time Frame: 6 months ]
  • Predictors of response (cardiac biomarkers, serum free light chains) [ Time Frame: 5 years ]
  • Safety and tolerability [ Time Frame: 5 years ]
  • Duration of response [ Time Frame: 10 years ]
  • Time to progression [ Time Frame: 5 years ]
  • Overall survival [ Time Frame: 10 yeras ]


Original Secondary Outcome: Same as current

Information By: PETHEMA Foundation

Dates:
Date Received: July 26, 2010
Date Started: October 2010
Date Completion:
Last Updated: April 23, 2017
Last Verified: November 2015