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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Multiple Myeloma Bone Lesions Behavior Blood Protein Disorders Bone Diseases Bone Resorption Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Motor Activity Multiple Myeloma Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Osteolysis Paraproteinemias Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heidelberg University Hospital - GMMG Study Group

Heidelberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise

Other

Orthopedic consultation and home-based, individualized, structured resistance training during induction therapy.

Control Group

Other

Orthopedic consultation and stretching exercises/walking. No resistance training.

Primary outcomes

Fatigue (MFI, Multidimensional Fatigue Inventory)

Time frame: From enrollment to the end of stem cell transplantation (approximately one year)

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Registry information

Official study title

Investigation of an Exercise Intervention for Multiple Myeloma Patients With Stable and Unstable Osteolytic Lesions During Induction Therapy.

Acronym: GMMG-HD8-INDEX

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Jun 18, 2025
Registry last updated: Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed