Results from a recent European Phase 3 clinical trial indicate that a few months of treatment with Velcade may improve the outcomes of multiple myeloma patients who recently underwent a stem cell transplant.

Specifically, patients who received Velcade (bortezomib) following transplantation, which is known as “consolidation therapy,” had a longer median progression-free survival than those who did not receive additional therapy after transplantation.  Their response to transplantation was also more likely to improve with Velcade consolidation therapy.

However, the researchers found that Velcade consolidation therapy appeared to be mainly effective in patients who had not achieved at least a very good partial response to their stem cell transplant.

Velcade consolidation therapy also did not impact overall survival, which the researchers attributed to effective treatment at progression.

Of note, only 4 percent of patients included in the study received a novel agent, all of whom received thalidomide (Thalomid), prior to Velcade consolidation therapy.

Patients reported that the main impact Velcade consolidation therapy had on quality of life was that they were more likely to feel fatigued.

Based on their findings, the researchers conclude that Velcade consolidation therapy after stem cell transplantation improves progression-free survival without interfering with quality of life.

However, the researchers recommend that Velcade consolidation therapy be studied further in combination with other drugs.

Background

Consolidation therapy is a short course of treatment used to improve a patient’s response to previous treatments. In many cases, it involves using the same drugs used in the patient’s initial therapy.

In contrast, maintenance therapy is a prolonged, often low-dose, form of treatment given after a patient’s initial therapy. It is used to prevent disease progression while also maintaining a favorable quality of life.

The study investigators state that the role of consolidation therapy and maintenance therapy in myeloma is still unclear.

Therefore, they assessed the efficacy and safety of Velcade consolidation therapy following stem cell transplantation to see if it would improve patient outcomes.

Study Design

Researchers from Denmark, Estonia, Finland, Iceland, Norway, and Sweden enrolled newly diagnosed myeloma patients in the study between October 2005 and April 2009.  The study included 187 patients who received Velcade consolidation therapy and 183 patients who received no consolidation therapy. The median age of the patients was 59 years.

All patients had previously received initial therapy and a stem cell transplant using the patient’s own stem cells (4 percent received two back-to-back stem cell transplants using their own stem cells).

Most patients (89 percent) were initially treated with cyclophosphamide (Cytoxan) and dexamethasone (Decadron). However, none of the patients had previously received Velcade.

Patients in the treatment group received 1.3 mg/m² Velcade for six cycles. For the first two cycles, patients received Velcade twice a week for two weeks, followed by a week of rest.  For the remaining four cycles, patients received Velcade once a week for three weeks, followed by a week of rest.

Study Results

During a median follow-up time of 38 months, more patients who received Velcade consolidation therapy experienced an improvement in their response to the transplant (57 percent), compared to those who did not receive consolidation therapy (36 percent).

The researchers note that Velcade consolidation therapy only benefitted patients who did not achieve at least a very good partial response after their transplant.

Patients who received Velcade consolidation therapy also had longer progression-free survival (27 months) than those who did not receive consolidation therapy (20 months).

However, the overall survival of both groups was the same (80 percent) after three years of follow-up time.

According to the researchers, the safety profile of Velcade consolidation therapy was acceptable.

The most common side effect was peripheral neuropathy (nerve damage to the extremities that can cause pain, tingling, or loss of sensation).  Peripheral neuropathy was more common in patients who received Velcade consolidation therapy (57 percent) than in those who did not receive consolidation therapy (24 percent).

The researchers also found that patients who received Velcade consolidation therapy more frequently reported fatigue and nausea or vomiting. However, the investigators said only the fatigue was a clinically significant change.

For more information, please see the study in the journal Blood (pdf).