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Prolonged Protection From Bone Disease in Multiple Myeloma (Magnolia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02286830
Recruitment Status : Recruiting
First Posted : November 10, 2014
Last Update Posted : October 12, 2017
Information provided by (Responsible Party):
Thomas Lund, Odense University Hospital

Brief Summary:

Main hypothesis: Patients who continue zoledronic acid after year 2 have longer time until progression in bone disease compared to patients who stop treatment after two years?

Secondary hypothesis: Serum will bone markers increase prior to progression in bone disease in the individual patient?

Secondary hypothesis: Low-dose CT will detect more cases of osteolytic bone disease in Multiple Myeloma compared to conventional radiography

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Zoledronic acid Phase 4

Detailed Description:

Newly diagnosed myeloma patients will be followed for 4 years. The first two years they will be treated with zoledronic acid monthly. At year 2 they will be randomized to A continue treatment for 2 more years or B stop treatment. The primary outcome of the study will be time to progressive bone disease from year 2 and onward.

Serum bone markers will be measured throughout the study. In patients who experience progressive bone disease, development of bone markers prior to the radiological progression will be investigated to see the if it could have been predicted with the use of serum markers

During the four year period patients will have low-dose CT superior and conventional radiography made at predefined time points. The secondary outcome of the study is to compare the sensitivity of the two modalities

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Magnolia Study Prolonged Protection From Bone Disease in Multiple Myeloma. An Open Label Phase 3 Multicenter International Randomised Trial
Study Start Date : January 2015
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: zoledronic acid
treatment with zoledronic acid for 4 years
Drug: Zoledronic acid
Zoledronic acid will be given to all participants for two years. Then patients will be randomized to A receive 2 more years of treatment or B stop treatment.
Other Name: Zometa

Placebo Comparator: no treatment
treatment with zoledronic acid withheld after two years
Drug: Zoledronic acid
Zoledronic acid will be given to all participants for two years. Then patients will be randomized to A receive 2 more years of treatment or B stop treatment.
Other Name: Zometa

Primary Outcome Measures :
  1. time to first skeletal related event after randomisations at year two [ Time Frame: From year two to year four ]
    After two years of zoledronic acid treatment patients will be randomized to A continue treatment B stop treatment.

Secondary Outcome Measures :
  1. Value of serum bone marker ratio (bone resorption / bone formation markers) as predictor of skeletal related related events analysed by time-dependent multiparameter Cox regression analysis. [ Time Frame: 4 years ]
    Development in bone markers prior to progression in osteolytic lesions will be investigated

Other Outcome Measures:
  1. Number of lesions identified with conventional radiography and low-dose CT [ Time Frame: 4 years ]
    Patients will have low-dose CT and conventional x-ray made at predefined time points to compare the sensitivity between the two modalities

  2. register incidence of osteonecrosis of the jaw [ Time Frame: 4 years ]
  3. register creatinine levels in serum [ Time Frame: 4 years ]

  4. register ionized calcium in serum [ Time Frame: 4 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Symptomatic Multiple Myeloma regardless of bone disease status
  • Signed Informed Consent
  • Age ≥ 18 years
  • Remaining life expectancy ≥ 2 years
  • Any concurrently anti-myeloma treatment are allowed

Exclusion Criteria:

  • Previous treatment with bisphosphonate within the last 6 months
  • Severely reduced renal function (creatinine clearance <30 mL/min despite fluid replacement)
  • Known concurrent malignancy, excluding skin cancer
  • Known hypersensitivity to zoledronic acid
  • Pregnant or lactating women
  • Women of childbearing potential or men engaging in sexual activity with a woman of childbearing potential who refuse to use contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02286830

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Contact: Thomas Lund, MD Ph.D. +45 21450256
Contact: Niels Abildgaard, MD Professor +45 65411155

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Odense University Hospital Recruiting
Odense C, Denmark, 5000
Contact: Thomas Lund    +45 21450256   
Principal Investigator: Thomas Lund         
Sponsors and Collaborators
Thomas Lund
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Principal Investigator: Thomas LunD, MD Ph.D. Department of hematology, Odense University Hospital, Denmark

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Responsible Party: Thomas Lund, MD Ph.D., Odense University Hospital Identifier: NCT02286830     History of Changes
Other Study ID Numbers: NMSG 22/14
2014-001121-32 ( EudraCT Number )
First Posted: November 10, 2014    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017

Keywords provided by Thomas Lund, Odense University Hospital:
zoledronic acid
bone markers
low-dose CT

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Bone Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Musculoskeletal Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs