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

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07026799

Acronym

GMMG-HD8-INDEX

Enrollment

Registered

2025-06-18

Start date

2023-04-14

Completion date

2026-06-27

Last updated

2025-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma Bone Lesions

Keywords

orthopaedic evaluation of bone stability, Multiple myeloma, Physical exercise, Osteolysis

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.

Interventions

OTHERExercise

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

OTHERControl group

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026