drugset / Trial / NCT01919086

Response Adapted Therapy With Bortezomib/Dexamethasone Followed by Addition of Lenalidomide in Non Responders as Initial Treatment for Patients With Multiple Myeloma

NCT01919086 ↗

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to see if researchers could get the same good results with less toxicity by using this new approach. We already know that the three drugs bortezomib, lenalidomide, and dexamethasone given together at the same time are effective. Most physicians therefore treat patients with multiple myeloma with the 3 drug combination. However, the researchers also know that the three drugs given together result in more side effects than when only 2 drugs (bortezomib and dexamethasone or lenalidomide and dexamethasone) are given. The researchers believe that all patients may not necessarily need the three drugs to have good results. In this study, the researchers will first treat your disease with bortezomib and dexamethasone. If the disease is not well controlled with these 2 drugs, only then the third drug, lenalidomide, will be added. By using this sequential approach we may reach the same good results with fewer side effects.

Timeline

Start
2013-08-06
Primary completion
2024-05-16
Completion
2024-05-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.5 mg/m2 Subcutaneous
Subject Dexamethasone Small molecule 20 mg Oral
Subject Dexamethasone Small molecule 40 mg Oral
Subject Lenalidomide Other / unclassified — —

Indications