Duration of bisphosphonate treatment in multiple myeloma

Phase 1

• Conditions: Multiple Myeloma.; MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002494-12-NO
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-06
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 358

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: Patients may be included when they have received two years of zoledronic acid treatment outside clinical trials. They will proceed directly to randomisation

Inclusion criteria (amendment)
- Earlier diagnosed with symptomatic Multiple Myeloma according to the IMWG criteria, regardless of bone disease status
-Signed Informed Consent
-Age = 18 years
-Remaining life expectancy = 1 years
-Received 23-25 monthly infusions with zoledronic acid
-Any concurrent anti-myeloma treatment are allowed

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

-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 (safe methods of contraception are considered to be: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system ( IUS) bilateral tubal occlusion, vasectomy, and sexual abstinence. Contraception must be used until 56 days after the last infusion).
- Progressive bone disease diagnosed using bone imaging, less than or equal to three month prior to the randomization
- Developed BON during earlier zoledronic acid treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.;Timepoint(s) of evaluation of this end point: After 358 patients with follow-up of at least 4 years