Clinical trial NCT07026799: Feasibility, Safety and Effectivity of an Exercise Intervention for Newly Diagnosed Multiple Myeloma Patients During Induction Therapy
Official title: Investigation of an Exercise Intervention for Multiple Myeloma Patients With Stable and Unstable Osteolytic Lesions During Induction Therapy.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Myeloma Bone Lesions
Keywords: orthopaedic evaluation of bone stability
Multiple myeloma
Physical exercise
Osteolysis
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Fatigue (MFI, Multidimensional Fatigue Inventory)
timeFrame: From enrollment to the end of stem cell transplantation (approximately one year)
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Heidelberg University Hospital - GMMG Study Group
Study officials:
References:
citation: Courneya KS, Vardy JL, O'Callaghan CJ, Gill S, Friedenreich CM, Wong RKS, Dhillon HM, Coyle V, Chua NS, Jonker DJ, Beale PJ, Haider K, Tang PA, Bonaventura T, Wong R, Lim HJ, Burge ME, Hubay S, Sanatani M, Campbell KL, Arthuso FZ, Turner J, Meyer RM, Brundage M, O'Brien P, Tu D, Booth CM; CHALLENGE Investigators. Structured Exercise after Adjuvant Chemotherapy for Colon Cancer. N Engl J Med. 2025 Jun 1. doi: 10.1056/NEJMoa2502760. Online ahead of print.
citation: Nicol JL, Woodrow C, Burton NW, Mollee P, Nicol AJ, Hill MM, Skinner TL. Physical Activity in People with Multiple Myeloma: Associated Factors and Exercise Program Preferences. J Clin Med. 2020 Oct 13;9(10):3277. doi: 10.3390/jcm9103277.
citation: Nicol JL, Hill MM, Burton NW, Skinner TL. Promoting exercise for patients with multiple myeloma: attitudes and practices of clinical haematologists. J Cancer Surviv. 2022 Jun;16(3):688-695. doi: 10.1007/s11764-021-01062-2. Epub 2021 Jun 11.
citation: Bower JE. Cancer-related fatigue--mechanisms, risk factors, and treatments. Nat Rev Clin Oncol. 2014 Oct;11(10):597-609. doi: 10.1038/nrclinonc.2014.127. Epub 2014 Aug 12.
citation: Christensen JF, Simonsen C, Hojman P. Exercise Training in Cancer Control and Treatment. Compr Physiol. 2018 Dec 13;9(1):165-205. doi: 10.1002/cphy.c180016.