Icon of the Instituts for Quality and Efficiency in Health Care

Dossier assessment

Daratumumab (smouldering multiple myeloma) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A25-109
Last updated

Report documents

  1. Extract of dossier assessment

    Daratumumab (smouldering multiple myeloma) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 647 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-109_en
    Download file : Extract of dossier assessment (PDF document, 647 kB, EN, not accessible)

  2. Dossier assessment

    Daratumumab (smouldering multiple myeloma) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 1 MB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-109
    Download file : Dossier assessment (PDF document, 1 MB, DE, not accessible)

Dossier assessment

Indication:

Adult patients with smouldering multiple myeloma who are at high risk of developing multiple myeloma

Result of dossier assessment:

Added benefit not proven

Press releases

Smouldering multiple myeloma: It remains unclear whether daratumumab prolongs life

As a large proportion of patients in the comparator arm of the main study did not receive appropriate treatment following progression to multiple myeloma, the key question for the benefit assessment is still unanswered.
Press release

Additional information

Federal Joint Committee (G-BA)

19-02-2026 A G-BA decision was published.
G-BA documents on this decision

Project details

Project no.
A25-109
Commission
Commission awarded on 18.08.2025 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Cancer
Note

After completion of the assessment by IQWiG the Federal Joint Committee (GBA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the GBA website.

DOI

https://doi.org/10.60584/A25-109_en

Connected Projects

  1. Dossier assessment

    Daratumumab (newly diagnosed multiple myeloma, ineligible for stem cell transplant) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A25-108
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Daratumumab (systemic light chain amyloidosis) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A25-40
    Last updated

    Status: Commission completed

  3. Dossier assessment

    Daratumumab (newly diagnosed multiple myeloma, suitable for autologous stem cell transplant) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A24-114
    Last updated

    Status: Commission completed

  4. Dossier assessment

    Daratumumab (multiple myeloma) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A23-127
    Last updated

    Status: Commission completed

  5. Dossier assessment

    Daratumumab (multiple myeloma) - Benefit assessment according to §35a Social Code Book V (expiry of the decision)

    Project no.
    A22-40
    Last updated

    Status: Commission completed

  6. Dossier assessment

    Daratumumab (newly diagnosed multiple myeloma, unsuitable for stem cell transplantation) - Benefit assessment according to §35a Social Code Book V (new scientific findings)

    Project no.
    A21-126
    Last updated

    Status: Commission completed

  7. Dossier assessment

    Daratumumab (multiple myeloma) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A21-101
    Last updated

    Status: Commission completed

  8. Dossier assessment

    Daratumumab (systemic light chain amyloidosis) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A21-100
    Last updated

    Status: Commission completed

  9. Dossier assessment

    Daratumumab (multiple myeloma, stem cell transplant) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A20-15
    Last updated

    Status: Commission completed

  10. Dossier assessment

    Daratumumab (multiple myeloma) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A20-14
    Last updated

    Status: Commission completed

  11. Dossier assessment

    Daratumumab (multiple myeloma) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A18-66
    Last updated

    Status: Commission completed

  12. Dossier assessment

    Daratumumab (multiple myeloma) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A17-40
    Last updated

    Status: Commission completed

  13. Dossier assessment

    Daratumumab - Assessment according to §35a (para. 1., sentence 10) Social Code Book V

    Project no.
    G16-02
    Last updated

    Status: Commission completed

  14. Addendum

    Daratumumab (smouldering multiple myeloma) – Addendum to Project A25-109

    Project no.
    A26-03
    Last updated

    Status: Commission completed

Contact

Press contact

+49 221 356850

press@iqwig.de

Info Service (German)

Subscribe to daily updated information on projects, calls for tender, current vacancies and events as well as our press releases.

Register

Contact form

Questions about commissions, publications and press releases can be sent to us via this form.

Contact form

Print page