NCT07388147

Brief Summary

Physical exercise is an important supportive therapy for cancer patients, as it improves quality of life in general and might mitigate the side effects of drug treatment. For patients with multiple myeloma in particular, significantly less evidence on the effectiveness of exercise therapy is available due to the fact that this disease is associated with severe bone degradation which might affect bone stability. Advances in oncologic drug treatment have improved overall survival in multiple myeloma significantly. Therefore, there is an increased interest for recommendations on physical activity in this patient group. Due to uncertainties regarding safety and feasibility of exercise therapy in multiple myeloma, both patients and therapists often remain hesitant. Therefore, an orthopaedic outpatient clinic has been established at the Myeloma Center of Heidelberg University Hospital. Here, patients receive consultation on bone stability and individualized physical exercise plans. Based on the expertise gained at the orthopaedic outpatient clinic, the aim of this study is to establish and evaluate structural measures for improved rehabilitation in multiple myeloma and to integrate them into routine clinical care.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
36mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Mar 2026Mar 2029

First Submitted

Initial submission to the registry

January 19, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

3.1 years

First QC Date

January 19, 2026

Last Update Submit

January 30, 2026

Conditions

Keywords

Implementation of structural measuresRehabilitationExercise therapyMultiple MyelomaBone lesions

Outcome Measures

Primary Outcomes (1)

  • Change in physical function

    Results of the EORTC QLQ-C30 questionnaire ("Physical functioning" scale)

    From enrollment to the end of induction therapy after 18 weeks

Study Arms (1)

Orthopedic consultation and exercise to evaluate structural measures and improve rehabilitation

ACTIVE COMPARATOR
Other: Orthopedic consultation and rehabilitation by excercise therapy

Interventions

All patients will receive a continuous orthopaedic consultation on bone stability and recommendations for exercise therapy during the different phases of systemic myeloma therapy. Thereby, structural measures to improve rehabilitation in multiple myeloma will be established and evaluated with the intention of integrating them into routine clinical care.

Orthopedic consultation and exercise to evaluate structural measures and improve rehabilitation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • newly diagnosed multiple myeloma
  • Survival prognosis \> 6 months
  • ECOG status ≤ 3
  • Age ≥18 years
  • Patients who state that they want to carry out the training program at least 2 x/week and participate in the planned follow-up visits
  • Ability to give informed consent
  • Written consent to participate in the study
  • Sufficient knowledge of written and spoken German

You may not qualify if:

  • physical or mental limitation that would prevent participation in the training program or the planned follow-up visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heidelberg University Hospital - GMMG Study Group

Heidelberg, 69120, Germany

Location

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

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

January 19, 2026

First Posted

February 4, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2029

Last Updated

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

* questionnaire results of each study participant * functional assessment of each study participant

Locations