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

NCT ID: NCT07026799

Last Updated: 2025-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-14

Study Completion Date

2026-06-27

Brief Summary

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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

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Conditions

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Multiple Myeloma Bone Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

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

Control group

Group Type OTHER

Control group

Intervention Type OTHER

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

Interventions

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Exercise

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

Intervention Type OTHER

Control group

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Heidelberg

OTHER

Sponsor Role lead

Responsible Party

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Ulrike Dapunt

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Heidelberg University Hospital - GMMG Study Group

Heidelberg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 40450658 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33066153 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34114194 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25113839 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30549018 (View on PubMed)

Other Identifiers

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S-165/2023

Identifier Type: -

Identifier Source: org_study_id

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