Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Subjects With Multiple Myeloma

Phase 1

• Conditions: Multiple Myeloma; MedDRA version: 14.1 Level: PT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-020454-34-ES
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-11
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1520

Inclusion Criteria

- Adults with newly diagnosed multiple myeloma;
- Radiographic evidence of at least 1 bone lesion;
- Plan to receive primary frontline anti-myeloma therapies;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2;
- Adequate organ function;
- Written informed consent.
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 560
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 960

Exclusion Criteria

- Nonsecretory multiple myeloma (unless baseline serum free light chain level is elevated);
- Plasma cell leukemia;
- Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome;
- Previous treatment with anti-myeloma therapy (does not include radiotherapy or a single short course of steroid [ie, less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days]). Anti-myeloma therapy (excluding bisphosphonates) may be started before randomization if the subject has signed informed consent and screening blood samples have been collected for central analysis.
- Planned radiation therapy or surgery to bone (does not include procedures;
performed before randomization)
- Prior administration of denosumab;
- Prior or current IV bisphosphonate administration;
- Use of oral bisphosphonates within the past 1 year;
- Prior history or current evidence of osteonecrosis/ osteomyelitis of the jaw.

Study & Design

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