Doxil Clinical Studies - Doxorubicin Clinical Studies - Myeloma


What have Doxil clinical trials shown?

Doxil clinical studies resulted in an FDA approval for multiple myeloma treatment.

Doxil clinical studies resulted in an FDA approval for multiple myeloma treatment.

Doxil® (doxorubicin HCl liposome injection, Janssen) was approved for use in combination with Velcade® (bortezomib, Takeda Oncology) to treat patients with myeloma who have not previously received Velcade and have received at least one prior therapy. The approval was based on results of a planned interim analysis of an international Phase III trial (DOXIL-MMY-3001) that compared the combination to Velcade alone in 646 patients with relapsed/refractory myeloma.

The results of this study show that showed that adding Doxil to the standard Velcade regimen reduced the risk of the disease progressing and prolonged the duration of response in patients with relapsed and refractory disease compared with Velcade alone.

  • The combination significantly extended the median time to disease progression (TTP) from 6.5 months to 9.3 months. The 15-month survival rate for Doxil plus Velcade was 76% compared with 65% for Velcade alone.
  • On average, responses to the combination lasted 10.2 months compared with 7 months with Velcade alone.
  • The benefits of the combination were consistently seen across a variety of patient types, including older patients, those with prior stem cell transplantation or exposure to Thalomid or doxorubicin, and patients with markers of high-risk disease.
  • After a follow-up of 8.6 years, overall survival was similar for patients in the Velcade-Doxil group and the Velcade group.

Learn about other FDA approved drugs for multiple myeloma treatment.

What have other clinical studies shown?

A variety of combination therapies that include Doxil have shown to be effective in patients who have previously received other therapies. Doxil has been combined with agents such as Velcade, Revlimid® (lenalidomide, Celgene), Thalomid® (thalidomide, Celgene), and/or dexamethasone in a number of 3- and 4-drug regimens.

Likewise, a variety of Doxil combination therapies have been shown to be effective in treating newly diagnosed myeloma. Examples include:

  • Doxil, Revlimid, and low-dose dexamethasone [Rachid AmJHematol 2014]
  • Revlimid, Velcade, Doxil, and dexamethasone [Jakubowiak Blood 2011]
  • Velcade and Doxil
  • Doxil, Velcade, Cyclophosphamide, and dexamethasone, a regimen referred to as ABCD

How is Doxil currently being studied in myeloma?

Doxil is being studied in combination with various approved and investigational agents for use in treating myeloma.

Interested in learning more about Doxil clinical trials? Talk to an MMRF Patient Support Nurse to learn more or use our clinical trials finder.