Feasibility, Safety and Effectivity of an Exercise Intervention for Newly Diagnosed Multiple Myeloma Patients During Induction Therapy

Not Applicable

Active, not recruiting

• Conditions: Multiple Myeloma Bone Lesions

• Registration Number: NCT07026799
• Lead Sponsor: University Hospital Heidelberg

Brief Summary

Physical exercise is an important supportive therapy for cancer patients, which improves quality of life and can effectively counteract the side effects of drug therapy. There is very little experience whether physical activity can also be performed safely by patients with malignant diseases that affect bone stability. This applies in particular to patients with multiple myeloma, a disease characterized by a monoclonal proliferation of plasma cells in the bone marrow and often accompanied by severe bony destruction. Aim of this exploratory randomized controlled trial is to evaluate feasibility, safety and effectivity of an orthopaedic-guided exercise intervention during induction therapy in newly diagnosed multiple myeloma patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-14
• Status Verified: 2025-06
• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Study First Posted: 2025-06-18
• Last Update Posted: 2025-06-18
• Primary Completion: 2026-06-27
• Study Completion: 2026-06-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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

Exclusion Criteria

• physical or mental limitation that would prevent participation in the training program or the planned follow-up visits.
• Carrying out a regular, intensive training program (min. 1h, 2x/week)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fatigue (MFI, Multidimensional Fatigue Inventory)	From enrollment to the end of stem cell transplantation (approximately one year)

Trial Locations

Locations (1)

Heidelberg University Hospital - GMMG Study Group; 🇩🇪 Heidelberg, Germany