Daratumumab (Darzalex) for the treatment of multiple myeloma

Introduction

Daratumumab (trade name: Darzalex) has been approved in Germany since May 2016 for the treatment of multiple myeloma. It is now an option for first-line treatment or subsequent treatment in the following groups of people:

  • First-line treatment in adults with a newly diagnosed myeloma who are able to have a stem cell transplant. Daratumumab is then combined with bortezomib, thalidomide and dexamethasone.
  • First-line treatment in adults with newly diagnosed myeloma who cannot have a stem cell transplant. Daratumumab is then combined either with bortezomib, melphalan and prednisone or with lenalidomide and dexamethasone.
  • Subsequent treatment in adults who have already received at least one course of treatment. In this group of people, daratumumab is either combined with lenalidomide and dexamethasone or with bortezomib and dexamethasone.
  • Subsequent treatment in adults who have had a recurrence of multiple myeloma and whose disease is difficult to treat. Daratumumab is an option for these people if they have already had treatment with a proteasome inhibitor and an immunomodulatory drug, and their last treatment wasn't effective enough.

Multiple myeloma is a rare type of cancer in which mutated plasma cells of the immune systemmultiply uncontrollably in the bone marrow. If the disease progresses, it destroys bone tissue and prevents normal blood formation. This can cause bone pain and bone fractures, as well as anemia.

It is divided into different stages according to the International Staging System (ISS). This categorization is mainly based on the amount of two proteins in the blood. There are three different stages: mild (ISS 1), moderate (ISS 2) and severe (ISS 3).

Daratumumab binds to cancer cells in order to destroy them. It is also supposed to stimulate the to attack the cancer cells.

Application

Daratumumab is given as an infusion (drip), and the dose is based on body weight. The number of infusions and the time intervals between infusions depend on factors such as previous treatments and the exact .

Other treatments

If an adult with a newly diagnosed melanoma is able to have a stem cell transplant, then it is done as part of a three-step treatment plan using various medications.

In adults with a newly diagnosed melanoma who aren't able to have a stem cell transplant, the first-line treatment options are thalidomide or bortezomib in combination with melphalan and prednisone, daratumumab in combination with bortezomib, melphalan and prednisone, or alternatively bortezomib, each in combination with lenalidomide and dexamethasone, and lenalidomide in combination with dexamethasone.

In patients who have already had at least one treatment, the standard treatment is bortezomib combined with doxorubicin or dexamethasone. Other options include lenalidomide in combination with dexamethasone, or elotuzumab in combination with lenalidomide and dexamethasone.

If multiple myeloma comes back after previous treatments, optimized individual therapy is the standard treatment option. The exact type of treatment used in this approach will depend on several things, such as which treatments have been tried before, and is adapted individually by a doctor.

Assessment

In 2020, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of daratumumab compared with the standard treatments for people with multiple myeloma.

The manufacturer provided two relevant studies for the following groups:

More information

This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the reviews and the hearings received, the G-BA passed a resolution on the added benefit of daratumumab (Darzalex) in newly diagnosed multiple myeloma if stem cell transplantation is an option, if stem cell transplantation is not an option (for the first or the second comparison treatment) and for previously treated multiple myeloma.

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Daratumumab (multiple myeloma) – Addendum to Commission A17-40; Commission A18-03. February 2, 2018. (IQWiG reports; Volume 589).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Daratumumab (multiple myeloma) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A17-40. November 13, 2017. (IQWiG reports; Volume 562).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Daratumumab (multiple myeloma) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A18-66. December 20, 2018. (IQWiG reports; Volume 698).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Daratumumab (multiple myeloma) – Addendum to Commission A18-66; Commission A19-16. February 28, 2019. (IQWiG reports; Volume 732).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Daratumumab (newly diagnosed multiple myeloma, stem cell transplantation not suitable) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A20-14. May 13, 2020. (IQWiG reports; Volume 913).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Daratumumab (newly diagnosed multiple myeloma, stem cell transplantation suitable) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A20-15. May 13, 2020. (IQWiG reports; Volume 914).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Updated on July 2, 2020
Next planned update: 2023

Authors/Publishers:

Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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