drugset / Trial / NCT01055301

S0833, Bortezomib, Thalidomide, Lenalidomide, Combination Chemotherapy, and Autologous Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma

NCT01055301 ↗

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as thalidomide and lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, cisplatin, doxorubicin hydrochloride, cyclophosphamide, etoposide, and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Combining chemotherapy with autologous stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Giving bortezomib, thalidomide, and combination chemotherapy before and after transplant and lenalidomide after transplant may be an effective treatment for multiple myeloma. PURPOSE: This phase II trial is studying how well giving bortezomib, thalidomide, and lenalidomide together with combination chemotherapy and autologous stem cell transplant works in treating patients with newly diagnosed multiple myeloma.

Timeline

Start
2011-07
Primary completion
2011-07
Completion
2011-07

Outcome

Outcome not reported

Stopped (Enrollment): “lack of accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 7.5 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 10 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 300 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 400 mg/m2 Intravenous
Subject Dexamethasone Small molecule 20 mg Oral
Subject Dexamethasone Small molecule 40 mg Oral
Subject Doxorubicin Other / unclassified 7.5 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 10 mg/m2 Intravenous
Subject Etoposide Small molecule 40 mg/m2 Intravenous
Subject Lenalidomide Other / unclassified 20 mg Oral
Subject Melphalan Small molecule 50 mg/m2 Intravenous
Subject Thalidomide Other / unclassified 50 mg Oral
Subject Thalidomide Other / unclassified 200 mg Oral

Indications