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New Drugs for Multiple Myeloma Consolidation Therapy
Untitled Document
Name of the Trial
Phase III Randomized Study of Consolidation Therapy Comprising Bortezomib and
Dexamethasone With Versus Without Lenalidomide in Patients With Symptomatic
Multiple Myeloma Who Have Completed a Dexamethasone-Based Induction Regimen
(ECOG-E1A05). See the protocol
summary.
Principal Investigators
Dr. Rafael Fonseca and Dr. S. Vincent Rajkumar, Eastern Cooperative Oncology
Group.
Why This Trial Is Important
Multiple myeloma is a type of cancer that begins in plasma cells, white blood
cells that are part of the immune system. In this
disease, malignant plasma
cells (myeloma cells) multiply and form small lesions in the bone marrow and
the solid parts of bone. Although multiple myeloma is usually not curable, advances
in drug treatment and the use of stem cell
transplantation have substantially
increased the average survival time of patients with this disease.
Patients with multiple myeloma are often treated first with chemotherapy drugs
and the steroid dexamethasone to induce remission (induction therapy). This
is often followed by "consolidation therapy" with high-dose chemotherapy
and stem cell transplantation. Although consolidation therapy has produced longer
survival, the side effects associated with it can be severe and may dramatically
affect quality of life. Doctors want to study new consolidation therapy options,
using recently developed drugs, to see if they can achieve the same or better
outcomes without as much risk to the patient.
In this trial, newly diagnosed patients who have undergone induction therapy
will be treated with consolidation therapy consisting of dexamethasone and the
drug bortezomib. Some patients will also be randomly assigned to receive a third
drug called lenalidomide. Both bortezomib and lenalidomide have been approved
by the FDA to treat patients with relapsed multiple myeloma, and they have shown
promise in early clinical trials involving patients with newly diagnosed disease.
"One of the biggest questions in the minds of patients in this era of
new drugs is, do we still need to have a transplant?" said Dr. Rajkumar.
"Autologous transplants are associated with significant morbidity and can be life changing. Both of these regimens hold the promise of high response rates
that may rival what we can achieve with stem cell transplantation while being
easier on patients."
For More Information
See the list of entry
criteria and trial contact information or call the NCI Cancer Information
Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is confidential.
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