drugset / Trial / NCT01440582

Combination Therapy of Lenalidomide/Bortezomib/Dexamethasone and Panobinostat in Transplant Eligible New Diagnosed Multiple Myeloma (MM) Patients

NCT01440582

Phase 1 Completed 77 enrolled M.D. Anderson Cancer Center Novartis · collab
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to find the highest tolerable dose of the drug panobinostat that can be given in combination with the drugs Velcade (bortezomib), Revlimid (lenalidomide), and Decadron (dexamethasone) to patients with MM. The safety of this drug combination will also be studied. Panobinostat is designed to cause chemical changes in different groups of proteins that are attached to DNA (the genetic material of cells), which may slow the growth of cancer cells or cause the cancer cells to die. Bortezomib is designed to block a protein that causes cells to grow. This may cause cancer cells to die. Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may slow the growth of cancer cells. Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body. Dexamethasone is often given to MM patients in combination with other chemotherapy to treat cancer.

Timeline

Start
2013-02-18
Primary completion
2019-02-28
Completion
2019-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.3 mg/m2 Subcutaneous
Subject Dexamethasone Small molecule 20 mg Oral
Subject Lenalidomide Other / unclassified 25 mg Oral
Subject Panobinostat Small molecule 10 mg Oral
Subject Panobinostat Small molecule 15 mg Oral

Indications