NCT07111884

Brief Summary

The goal of this observational study is to collect long-term clinical follow-up data on patients with multiple myeloma who participated in a therapy study of the German-Speaking Myeloma Multicenter Group (GMMG). Target variables of interest are: Overall survival, progression-free survival and follow-up time. The relevant registry data will be provided and evaluated together with the therapy study data for scientific research projects. This allows seamless documentation of patient data from the end of the trial to long-term follow-up.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
999

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Dec 2022

Longer than P75 for all trials

Geographic Reach
1 country

35 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Dec 2022Mar 2027

Study Start

First participant enrolled

December 8, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2024

Completed
1 year until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

4.2 years

First QC Date

July 30, 2024

Last Update Submit

August 5, 2025

Conditions

Multiple Myeloma

Keywords

registrylongtime follow-upelotuzumabreal world data

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    after 5 years, and then through study completion, an average of 1 year

Other Outcomes (4)

  • overall survival

    after 5 years, and then through study completion, an average of 1 year

  • follow-up time

    after 5 years, and then through study completion, an average of 1 year

  • cause of death

    after 5 years, and then through study completion, an average of 1 year

  • +1 more other outcomes

Study Arms (1)

Patient with multiple myeloma

newly- diagnosed, transplant eligible multiple myeloma patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with newly-diagnosed, transplant-eligible multiple myeloma

You may qualify if:

  • Previous participation in a a therapy study of the GMMG study group

You may not qualify if:

  • patients with organ amyloidosis at time of diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

HELIOS Klinikum, Klinik für Hämatologie, Onkologie und Immunologie

Berlin, 13125, Germany

RECRUITING

Charité Campus Benjamin Franklin, III. Med. Abt. (Hämatologie/Onkologie)

Berlin, D-12200, Germany

RECRUITING

Klinikum Bielefeld, Klinik für Hämatologie, Onkologie und Palliativmedizin

Bielefeld, D-33604, Germany

RECRUITING

Medizinische Universitätsklinik, Knappschaftskrankenhaus

Bochum, D-44892, Germany

RECRUITING

Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III, Schwerpunkt Onkologie, Hämatologie und Rheumatologie

Bonn, 53127, Germany

RECRUITING

Klinikum Chemnitz GmbH, Innere Medizin III

Chemnitz, D-09116, Germany

RECRUITING

Universitätsklinikum Köln, Klinik I - Innere Medizin

Cologne, D-50937, Germany

RECRUITING

Onkologisches Studienzentrum Darmstadt

Darmstadt, 64287, Germany

RECRUITING

Klinikum Darmstadt, Med. Klinik V, Hämatologie/Onkologie

Darmstadt, D-64283, Germany

RECRUITING

Universitätsklinikum Düsseldorf, Klinik für Hämatologie,Onkologie und Klin. Immunologie

Düsseldorf, D-40225, Germany

RECRUITING

Universitätsklinik Erlangen

Erlangen, 91054, Germany

RECRUITING

Universitätsklinikum Essen, Klinik für Hämatologie und Stammzelltransplantation

Essen, D-45147, Germany

RECRUITING

Ev. Krankenhaus Essen-Werden gGmbH, Zentrum für Innere Medizin, Klinik für Hämatologie, Onkologie und Stammzelltransplantation

Essen, D-45239, Germany

RECRUITING

Universitätsklinikum Frankfurt, Goethe-Universität Medizinische Klinik II

Frankfurt am Main, 60590, Germany

RECRUITING

Justus-Liebig-Universität, Medizinische Klinik IV

Giessen, 35385, Germany

RECRUITING

Kath. Krankenhaus Hagen GmbH, Abt. Hämatologie/Onkologie

Hagen, D-58097, Germany

RECRUITING

Asklepios Klinik Hamburg Altona, II. Med. Klinik

Hamburg, D-22763, Germany

RECRUITING

Onkologische Schwerpunktpraxis

Heidelberg, 69115, Germany

RECRUITING

University Hospital Heidelberg, Med. Klinik V

Heidelberg, D-69120, Germany

RECRUITING

SLK Kliniken Heilbronn, Med. Klinik III

Heilbronn, D-74078, Germany

RECRUITING

Universitätsklinikum des Saarlandes, Innere Medizin I

Homburg, 66421, Germany

RECRUITING

Westpfalz-Klinikum GmbH

Kaiserslautern, 67655, Germany

RECRUITING

Praxisklinik für Hämatologie und Onkologie

Koblenz, D-56068, Germany

RECRUITING

Onkologisches Zentrum, Gemeinschaftspraxis f. Hämatologie u. Onkologie im Caritas KH

Lebach, 66822, Germany

RECRUITING

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, III. Med. Klinik

Mainz, D-55131, Germany

RECRUITING

III. Medizinische Klinik Hämatologie und Internistische Onkologie

Mannheim, 68167, Germany

RECRUITING

Mannheimer Onkologie Praxis

Mannheim, D-68161, Germany

RECRUITING

Philipps-Universität Marburg, Hämatologie/Onkologie/Immunologie

Marburg, 35032, Germany

RECRUITING

Krankenhaus Maria Hilf GmbH, Franziskuskrankenhaus, Med. Klinik I

Mönchengladbach, D-41063, Germany

RECRUITING

Krankenhaus Barmherzige Brüder, Klinik für Onkologie und Hämatologie

Regensburg, 93049, Germany

RECRUITING

Diakonie-Klinikum Schwäbisch Hall gGmbH, Innere Medizin III

Schwäbisch Hall, 74523, Germany

RECRUITING

ZAHO-Zentrum für ambulante Hämatologie und Onkologie, Standort Siegburg

Siegburg, D-53721, Germany

RECRUITING

Diakonissen-Stiftungs-Krankenhaus Speyer

Speyer, D-67346, Germany

RECRUITING

Klinikum Mutterhaus der Borromäerinnen gGmbH

Trier, 54290, Germany

RECRUITING

University Hospital Tübingen, Med. Klinik und Poliklinik, Abt. II

Tübingen, D-72076, Germany

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Hartmut Goldschmidt, Prof.

    University Hospital Heidelberg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eileen Kurre

CONTACT

+49 6221 56-8246eileen.kurre@med.uni-heidelberg.de

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of GMMG- study group

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 8, 2025

Study Start

December 8, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

August 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Publications

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
anticipated after end registry

Locations

DE(35)