Patients with confirmed multiple myeloma stage II-III according to Salmon and Durie, where treatment with bisphosphonate is indicated. MedDRA version: 8.1 Level: PT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Trade Name: Bondronat 6mg/6ml concentrate for solution for infusion
Product Name: Bondronat 6 mg/6 ml
Product Code: Ro 200-5450
Pharmaceutical Form: Concentrate for solution for infusion
INN or Propos
Sponsors
Roche Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Confirmed multiple myeloma stage II-III according to Salmon and Durie, where treatment with bisphosphonate is indicated. 2. Willingness to give written informed consent, written consent for data protection (legal requirement in Germany: datenschutzrechtliche Einwilligung) and willingness to participate and to comply with the study. 3. Age = 18 years. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous treatment with Ibandronate or Zoledronate within the last 12 months; previous treatment with other bisphosphonates is permissible (in case of intravenous bisphosphonate treatment: period between last infusion and screening = 3 weeks). 2. Renal insufficiency with a serum creatinine > 3.0 mg/dl or > 265 µmol/l or a creatinine clearance < 30 ml/min (Cockcroft-Gault formula) based on the values determined by the central laboratory. 3. Hypersensitivity to Ibandronate, Zoledronate or other bisphosphonates. 4. The presence of secondary malignant neoplasms, except for basalioma or cervical carcinoma in situ. 5. Serious concomitant organic disease. 6. Difficult to control insulin-dependent diabetes mellitus. 7. Glaucoma or phaeochromocytoma. 8. Acute myocardial infarction within the last six months. 9. Patients proven to have HIV infection. 10. As the following medication(s) can have interactive effects and may interfere with the patient's ability to meet the study requirements, they cannot be administered during the clinical study: Aminoglycosides. 11. Chemotherapy with Cisplatin or Methotrexate at study start. 12. Osteonecrosis of the jaw at study start. 13. Planned invasive dental intervention (e.g. extraction). 14. Life expectancy of <= 12 months. 15. Women lactating, pregnant or of childbearing potential not using a highly effective contraceptive method (allowed methods of birth control, i.e. with a failure rate of less than 1 % per year, are implants, injectables, combined oral contraceptives, IUDs (only hormonspirals), secual absti-nence or vasectomized partner). Women of childbearing potential must have a negative pregnancy test (serum, ß HCG) at visit 1. 16. Treatment with a medicinal product that has not yet been approved (with the exception of Thalidomide) during the study or within the last 30 days or 7 half lives, whichever is the longer. 17. Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study. 18. Patients who participates currently in another clinical trial or patients who participated in another clinical trial during the study or within the last 30 days or 7 half lives, whichever is the longer. 19. Patients who have participated in this study before. 20. Patients who are underage or patients who are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4 and § 41 Abs. 2 und Abs. 3 AMG). 21. Patients who possibly are dependent on the sponsor or investigator. 22. Patients who are scheduled for allogenic stem cell transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of renal safety under treatment with 6 mg Ibandronate or 4 mg Zoledronate i.v. over 15 min. The only primary target variable is the ratio of patients with deterioration of the renal function. Considered as a relevant deterioration is a decrease of creatinine clearance (calculated according to Cockcroft-Gault) of 30 % or a decline to = 30ml/min.;Secondary Objective: 1. Time until the first skeletal event (SRE, skeletal related events). 2. Number of skeletal events in the respective treatment group. 3. Number of patients with at least one skeletal event. 4. Number of osteonecrosis of the jaw. 5. Frequency of dose reduction under Zoledronate as absolute value. 6. Percentage deterioration baseline at 44 week value and baseline at 92 week value of N-acetyl-ß-D-glucosaminidase, a1-microglobulin and ?-glutamyl-transferase. 7. Percentage of patients with an increase of the serum creatinine value of more than 0.5 mg/dl (in patients with an inital serum creatinine level < 1.4 mg/dl) or 1.0 mg/dl (in patients with an initial serum creatinine level =1.4 mg/dl) versus baseline after 44 or 92 weeks (measured in the central laboratory). 8. Evaluation of the percentage drop in creatinine clearance baseline at 44 week value and baseline at 92 week value. ;Primary end point(s): The renal safety will be evaluated by the number of patients with increase in serum creatinine value by more than 0.5 mg/dl (in patients with an initial serum creatinine level of < 1.4 mg/dl) or 1.0 mg/dl (in patients with an initial serum creatinine level = 1.4 mg/dl). | — |
Countries
Germany
Outcome results
None listed