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Posted by on Nov 28, 2020 in Multiple Myeloma | 0 comments

In a nutshell

This study investigated whether giving patients with relapsed/resistant multiple myeloma (MM) venetoclax (Venclexta), in combination with bortezomib (Velcade) and dexamethasone (Ozurdex), will improve patient survival. This study showed that these patients would benefit from this treatment combination.

Some background

MM is a type of blood cancer. A high number of patients with MM relapse (the tumor grows after treatment) or are resistant to therapy (refractory). A standard treatment for relapsed/refractory (r/r) MM is bortezomib in combination with dexamethasone (Vd regimen). However, many patients still relapse after this treatment.

Cell death is important for controlling cancer growth and development. Often, correct cell death is prevented in tumors, allowing them to survive. The BCL-2 protein is involved in blocking cell death. Cancer cells can rely heavily on BCL-2 to survive. Therapy that blocks this BCL-2 protein such as venetoclax can make it easier to kill cancer cells.

Venetoclax is used alone or in combination with other medication for the treatment of other blood cancers such as leukemia or lymphoma. A small study has shown that venetoclax in combination with Vd could be effective in patients with r/r MM. However, results in larger populations are still needed.

Methods & findings

291 patients with r/r MM were enrolled in this trial. Patients were randomly assigned to receive either Vd plus venetoclax or Vd plus placebo. The average follow-up period was 18.7 months.

Patients in the venetoclax group had an average survival without cancer worsening of 22.4 months compared to 11.5 months in the placebo group. Patients in the venetoclax group were 37% less likely to have the disease progress compared to the placebo group.

Overall, 85% of the patients in the venetoclax group had treatment response compared to 70% in the placebo group. However, this benefit in response to venetoclax was not seen in patients with low levels of BCL2 protein and genetic changes such as t(11;14).

99% of patients in both groups reported side effects. 63% of patients in the venetoclax group and 78% in the placebo group dropped out of the trial because of the side effects. These included pneumonia, diarrhea, and generalized infection. 

The bottom line

This study concluded that venetoclax in combination with Vd improved survival in patients with r/r MM.

The fine print

This study had a small sample size. A small number of patients had the t(11;14) genetic change, so it is hard to draw a conclusion from this group. This study was funded by AbbVie and Genentech, the manufacturers of venetoclax.

Published By :

The Lancet. Oncology

Date :

Oct 29, 2020

Original Title :

Venetoclax or placebo in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (BELLINI): a randomised, double-blind, multicentre, phase 3 trial.

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