drugset / Trial / NCT01554852

Use of Thalidomide, Lenalidomide, Carfilzomib, Bortezomib and Vorinostat in the Initial Treatment of Newly Diagnosed Multiple Myeloma Patients

NCT01554852

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare a standard chemotherapy regimen of cyclophosphamide, dexamethasone plus thalidomide with a newer regimen of cyclophosphamide, dexamethasone plus lenalidomide with or without carfilzomib. Patients who do not have the best response to their initial treatment may then also be given a combination of cyclophosphamide, dexamethasone plus bortezomib. Patients who are relatively fit may, on their doctor's advice, go on to receive more intensive chemotherapy, supported with a transplant of their own blood cells. This is standard treatment which patients may be offered anyway even if they didn't take part in this study. After maximal response has been achieved with the treatment described above, and as long as the myeloma has not got worse, patients will be treated with either long-term lenalidomide, lenalidomide with vorinostat, or receive no further treatment, with close observation.

Timeline

Start
2010-05
Primary completion
2021-12
Completion
2022-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bortezomib Small molecule 1.3 mg/m2 Subcutaneous
Comparator Carfilzomib Other / unclassified 36 mg/m2 Intravenous
Comparator Cyclophosphamide Other / unclassified 500 mg Oral
Comparator Dexamethasone Small molecule 20 mg Oral
Comparator Dexamethasone Small molecule 40 mg Oral
Comparator Lenalidomide Other / unclassified 10 mg Oral
Comparator Lenalidomide Other / unclassified 25 mg Oral
Comparator Thalidomide Other / unclassified 200 mg Oral
Comparator Vorinostat Small molecule 300 mg Oral
Comparator Melphalan Small molecule

Indications