Prolonged Protection From Bone Disease in Multiple Myeloma (Magnolia)

February 16, 2023 updated by: Thomas Lund

Magnolia Study Prolonged Protection From Bone Disease in Multiple Myeloma. An Open Label Phase 3 Multicenter International Randomised Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

158

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense C, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Zometa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From year two to year four

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 years
register incidence of osteonecrosis of the jaw
Time Frame: 4 years
4 years
register creatinine levels in serum
Time Frame: 4 years
nephrotoxicity
4 years
register ionized calcium in serum
Time Frame: 4 years
hypocalcemia
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Lund

Investigators

  • Principal Investigator: Thomas LunD, MD Ph.D., Department of hematology, Odense University Hospital, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

February 16, 2023

Study Completion (Actual)

February 16, 2023

Study Registration Dates

First Submitted

March 12, 2014

First Submitted That Met QC Criteria

November 7, 2014

First Posted (Estimate)

November 10, 2014

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMSG 22/14
  • 2014-001121-32 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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