Daratumumab (Darzalex) as first-line treatment in combination with lenalidomide and dexamethasone if a stem cell transplantation is not an option

In 2020 the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of daratumumab in combination with lenalidomide and dexamethasone for the treatment of newly diagnosed multiple myeloma in people who can't have a stem cell transplantation.

The manufacturer gave IQWiG one ongoing study that provided at least some preliminary answers. A total of 737 patients participated in the study. 369 of them were given lenalidomide and dexamethasone, and 368 of them also received daratumumab.

These are the findings so far:

What are the advantages of daratumumab?

Pain: Early analyses suggest that the additional use of daratumumab has an advantage here: The pain got worse after an average (median) of about 35 weeks when daratumumab was added to the treatment, compared to after only 18 weeks when daratumumab was not used.

Physical and social functioning: Early analyses suggest that the additional use of daratumumab has an advantage in terms of these aspects of health-related quality of life. People who also used daratumumab were better able to manage the physical activities of their everyday life such as shopping, eating or personal hygiene. They also felt less restricted in their family life, when doing things with friends and during other social activities.

Severe skin problems: Early analyses suggest that the additional use of daratumumab has an advantage regarding this side effect.

Severe anemia: Early analyses suggest that the additional use of daratumumab has an advantage here too.

What are the disadvantages of daratumumab?

Severe side effects: Early analyses suggest that the additional use of daratumumab has a disadvantage here: People who also used daratumumab developed severe side effects after an average (median) of just under 1 month, compared to nearly 2 months in people who did not use daratumumab. These severe side effects included severe neutropenia (low numbers of cells).

Side effects: Early analyses suggest that using daratumumab in addition to the other medications has a disadvantage in terms of various side effects:

  • Infections
  • Chills
  • Diseases of the airways

No difference

Life expectancy: There was no difference between the groups here.

General health: There was no relevant difference between the two groups here, either. The patients in the study were asked to rate their own general health.

Symptoms of the disease: There was no difference regarding the following symptoms:

  • Breathing problems
  • Exhaustion
  • Nausea and vomiting
  • Sleep problems, loss of appetite
  • Constipation
  • Diarrhea

Health-related quality of life: There was no difference here in terms of

  • how much people felt limited in their everyday life, their free time or at work (role functioning)
  • how well they were able to concentrate or remember things (cognitive functioning)
  • how relaxed, tense or down they felt (emotional functioning)
  • how they rated their overall health and quality of life (global health status)

What remains unanswered?

The manufacturer didn’t provide any information about treatment stopped due to side effects or possible reactions to the daratumumab infusions.

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).

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.

Comment on this page

What would you like to share with us?

We welcome any feedback and ideas. We will review, but not publish, your ratings and comments. Your information will of course be treated confidentially. Fields marked with an asterisk (*) are required fields.

Please note that we do not provide individual advice on matters of health. You can read about where to find help and support in Germany in our information “How can I find self-help groups and information centers?

Created on July 2, 2020
Next planned update: 2023

Authors/Publishers:

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

How we keep you informed

Follow us on Twitter or subscribe to our newsletter or newsfeed. You can find all of our films online on YouTube.