Duration of bisphophonate treatment in multiple myeloma

Magnolia Study Prolonged Protection from Bone Disease in Multiple Myeloma. An open label phase 3 multicenter international randomised trial

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002494-12-DK

Enrollment

358

Registered

2014-10-14

Start date

2014-10-14

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma. MedDRA version: 21.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864

Interventions

Trade Name: Zoledronic Acid Product Name: Zoledron acid Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ZOLEDRONIC ACID

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Symptomatic Multiple Myeloma according to the IMWG criteria, regardless of bone disease status -Signed Informed Consent -Age = 18 years -Remaining life expectancy = 2 years -Any concurrently anti-myeloma treatment are allowed. Amendment 5.0: Patients may be included after 2 years of zoledronic acid treatment outside clinical trial, and then proceed directly to randomisation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 143 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 215

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: After 358 patients with follow-up of at least 4 years;Main Objective: To compare the time to PBD from year 2 to year 4 in patients treated with monthly zoledronic acid in two consecutive years compared to patients treated with monthly zoledronic acid in four consecutive years.; Secondary Objective: compare low dose CT to conventional radiograhpy. investigate serum bone markers in multiple myeloma ;Primary end point(s): To compare the time to PBD from year 2 to year 4 in patients treated with monthly zoledronic acid in two consecutive years compared to patients treated with monthly zoledronic acid in four consecutive years.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: After 358 patients with follow-up of at least 4 years;Main Objective: To compare the time to PBD from year 2 to year 4 in patients treated with monthly zoledronic acid in two consecutive years compared to patients treated with monthly zoledronic acid in four consecutive years.; Secondary Objective: compare low dose CT to conventional radiograhpy. investigate serum bone markers in multiple myeloma ;Primary end point(s): To compare the time to PBD from year 2 to year 4 in patients treated with monthly zoledronic acid in two consecutive years compared to patients treated with monthly zoledronic acid in four consecutive years.

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Secondary

Measure	Time frame
Secondary end point(s): To compare the incidence of PBD from year 2 to year 4 in patients treated with monthly zoledronic acid in two consecutive years compared to patients treated with monthly zoledronic acid in four consecutive years. To compare the incidence of sPBD from year 2 to year 4 in patients treated with monthly zoledronic acid in two consecutive years compared to patients treated with monthly zoledronic acid in four consecutive years. To compare the incidence of bone healing from year 2 to year 4 in patients treated with monthly zoledronic acid in two consecutive years compared to patients treated with monthly zoledronic acid in four consecutive years. To compare the overall survival from year 2 to year 4 in patients treated with monthly zoledronic acid in two consecutive years compared to patients treated with monthly zoledronic acid in four consecutive years. To compare the incidence of BON from year 2 to year 4 in patients treated with monthly zoledronic acid in two consecutive years compared to patients treated with monthly zoledronic acid in four consecutive years. To compare the development in QoL from year 2 to year 4 in patients treated with monthly zoledronic acid in two consecutive years compared to patients treated with monthly zoledronic acid in four consecutive years. To compare the development in the bone markers CTX-I, PINP, bALP, and TRAP5b from year 2 to year 4 in the patients groups randomised to receive two or four years of treatment with zoledronic acid To investigate in monthly measurements of the bone markers CTX-I, PINP, bALP, TRAP5b, or the ratios of these can be used to predict the development of PBD from year 2 to year 4. To investigate the consistency between the diagnose “no bone disease” when using conventional radiography compared to low-dose CT at diagnosis*. To investigate	—

Measure

Time frame

Secondary end point(s): To compare the incidence of PBD from year 2 to year 4 in patients treated with monthly zoledronic acid in two consecutive years compared to patients treated with monthly zoledronic acid in four consecutive years. To compare the incidence of sPBD from year 2 to year 4 in patients treated with monthly zoledronic acid in two consecutive years compared to patients treated with monthly zoledronic acid in four consecutive years. To compare the incidence of bone healing from year 2 to year 4 in patients treated with monthly zoledronic acid in two consecutive years compared to patients treated with monthly zoledronic acid in four consecutive years. To compare the overall survival from year 2 to year 4 in patients treated with monthly zoledronic acid in two consecutive years compared to patients treated with monthly zoledronic acid in four consecutive years. To compare the incidence of BON from year 2 to year 4 in patients treated with monthly zoledronic acid in two consecutive years compared to patients treated with monthly zoledronic acid in four consecutive years. To compare the development in QoL from year 2 to year 4 in patients treated with monthly zoledronic acid in two consecutive years compared to patients treated with monthly zoledronic acid in four consecutive years. To compare the development in the bone markers CTX-I, PINP, bALP, and TRAP5b from year 2 to year 4 in the patients groups randomised to receive two or four years of treatment with zoledronic acid To investigate in monthly measurements of the bone markers CTX-I, PINP, bALP, TRAP5b, or the ratios of these can be used to predict the development of PBD from year 2 to year 4. To investigate the consistency between the diagnose “no bone disease” when using conventional radiography compared to low-dose CT at diagnosis*. To investigate

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Countries

Denmark, Norway, Sweden

Contacts

Public ContactThomas Lund

Odense University Hospital

thomas.lund1@rsyd.dk+4565414855

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026