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

NCT07026799 | Active Not Recruiting

• 1 other identifier: S-165/2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma Bone Lesions

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Fatigue (MFI, Multidimensional Fatigue Inventory)

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

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Other: Exercise

Control group

OTHER

Other: Control group

Interventions

Exercise OTHER

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

Intervention group

Control group OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• Carrying out a regular, intensive training program (min. 1h, 2x/week)

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

Heidelberg University Hospital - GMMG Study Group

Heidelberg, 69120, Germany

Location

Related Publications (5)

• 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 Jul 3;393(1):13-25. doi: 10.1056/NEJMoa2502760. Epub 2025 Jun 1.

  PMID: 40450658 BACKGROUND

• 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.

  PMID: 33066153 BACKGROUND

• 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.

  PMID: 34114194 BACKGROUND

• 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.

  PMID: 25113839 BACKGROUND

• 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.

  PMID: 30549018 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma; Motor Activity; Osteolysis

Interventions

Exercise; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 18, 2025
• Study Start: April 14, 2023
• Primary Completion (Estimated): June 27, 2026
• Study Completion (Estimated): June 27, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)