Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Subjects With Multiple Myeloma
This study is currently recruiting participants.
(see Contacts and Locations)
Verified October 2014 by Amgen
Sponsor:
Amgen
Collaborator:
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01345019
First received: April 28, 2011
Last updated: October 22, 2014
Last verified: October 2014
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Purpose
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone disease from multiple myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Hematologic Malignancies Multiple Myeloma Oncology Bone Metastases Multiple Myeloma Bone Lesions |
Drug: Denosumab Drug: Zoledronic acid |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Disease in Subjects With Newly Diagnosed Multiple Myeloma |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Time to the first on-study skeletal related event (SRE) (non-inferiority test) [ Time Frame: Approximately 48 months ] [ Designated as safety issue: No ]Until approximately 800 subjects have experienced at least one on-study SRE (anticipated to be approximately 48 months).
Secondary Outcome Measures:
- Time to the first-and-subsequent SRE (superiority test, using multiple event analysis) [ Time Frame: Approximately 48 months ] [ Designated as safety issue: No ]Until approximately 800 subjects have experienced at least one on-study SRE (anticipated to be approximately 48 months)
- Time to the first on-study SRE (superiority test) [ Time Frame: Approximately 48 months ] [ Designated as safety issue: No ]Until approximately 800 subjects have experienced at least one on-study SRE (anticipated to be approximately 48 months)
| Estimated Enrollment: | 1520 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | October 2018 |
| Estimated Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Zoledronic acid 4 mg IV and Placebo SC
Zoledronic acid 4 mg (adjusted for renal function) IV over at least 15 minutes + Placebo SC Q4W (n = 760)
|
Drug: Zoledronic acid
Zoledronic acid 4 mg (adjusted for renal function) IV over at least 15 minutes Q4W (n = 760)
|
|
Experimental: Denosumab 120 mg SC and Placebo IV
Denosumab 120 mg SC + Placebo IV over at least 15 minutes Q4W (n = 760)
|
Drug: Denosumab
Denosumab 120 mg SC
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Documented evidence of multiple myeloma
- Monoclonal plasma cells in the bone marrow greater than or equal to 10% and/or presence of a biopsy-proven plasmacytoma
- Monoclonal protein present in the serum and/or urine
- Radiographic (ie, X-ray, or computer tomography [CT]) evidence of at least 1 lytic bone lesion (or at least 1 focal lesion per magnetic resonance imaging [MRI])
- Plan to receive or is receiving primary frontline anti-myeloma therapies
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Written informed consent before any study-specific procedure is performed
Exclusion Criteria:
- Nonsecretory multiple myeloma based upon standard M-component criteria (ie, measurable serum/urine M-component) unless the baseline serum free light chain level is elevated
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Plasma cell leukemia
- More than 30 days of previous treatment (before screening) 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 60 mg/day for 4 days]).
- Planned radiation therapy or surgery to the bone (does not include procedures performed before randomization)
- Prior administration of denosumab
- More than 1 previous dose of IV bisphosphonate administration
- Use of oral bisphosphonates with a cumulative exposure of more than 1 year
- Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
- Active dental or jaw condition which requires oral surgery, including tooth extraction
- Non-healed dental/oral surgery, including tooth extraction
- Planned invasive dental procedures
- Subject is pregnant or breast feeding, or planning to become pregnant within 7 months after end of treatment
- Subject has known sensitivity to any of the products to be administered during the study (eg, mammalian derived products, calcium or vitamin D)
- Other criteria may apply
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345019
Show 294 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345019
Contacts
| Contact: Amgen Call Center | 866-572-6436 |
Show 294 Study Locations
Sponsors and Collaborators
Amgen
Daiichi Sankyo Inc.
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01345019 History of Changes |
| Other Study ID Numbers: | 20090482 |
| Study First Received: | April 28, 2011 |
| Last Updated: | October 22, 2014 |
| Health Authority: | Switzerland: Swissmedic (Swiss Agency for Therapeutic Products) Taiwan: Taiwan Provincial Department of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration Australia: Therapeutic Goods Administration Czech Republic: State Institute for Drug Control France: European Medicines Agency France: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices Greece: Ministry of Health & Social Solidarity, National Organization for Medicines Hungary: National Institute of Pharmacy Ireland: Irish Medicines Board Italy: Ministry of Health Japan: Pharmaceuticals and Medical Devices Evaluation Center New Zealand: Medicines and Medical Devices Safety Authority Poland: Central Ethics Committee Poland: Ministry of Health Portugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED) Portugal: National Institute of Pharmacy and Medicines Spain: Spanish Agency of Medicines Austria: Agency for Health and Food Safety Canada: Ethics Review Committee Canada: Health Canada Bulgaria: Bulgarian Drug Agency Bulgaria: Ministry of Health Russia: Ethics Committee Russia: Pharmacological Committee, Ministry of Health Russia: FSI Scientific Center of Expertise of Medical Application Turkey: Ethics Committee Turkey: Ministry of Health Hong Kong: Ethics Committee Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee Malaysia: Ministry of Health Singapore: Clinical Trials & Epidemiology Research Unit (CTERU) Singapore: Domain Specific Review Boards Singapore: Health Sciences Authority South Korea: Institutional Review Board South Korea: Korea Food and Drug Administration (KFDA) Ukraine: Ministry of Health Ukraine: State Pharmacological Center - Ministry of Health Slovakia: State Institute for Drug Control Lithuania: Bioethics Committee Lithuania: State Medicine Control Agency - Ministry of Health |
Keywords provided by Amgen:
|
myeloma multiple myeloma zoledronic acid hematologic malignancies SRE skeletal-related event blood cancer lytic bone lesions bone metastases fractures spinal cord compression radiation to bone surgery to bone bisphosphonates |
Neoplasms, Plasma Cell Paraproteinemias Neoplasms Neoplasm Metastasis Bone Neoplasms Bone Marrow Diseases Blood Protein Disorders Hematologic Diseases denosumab Neoplastic Processes Bone Diseases Diphosphonates Bone Density Conservation Agents |
Additional relevant MeSH terms:
|
Multiple Myeloma Bone Diseases Neoplasm Metastasis Neoplasms Neoplasms, Plasma Cell Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders |
Lymphoproliferative Disorders Musculoskeletal Diseases Neoplasms by Histologic Type Neoplastic Processes Paraproteinemias Pathologic Processes Vascular Diseases Bone Density Conservation Agents Diphosphonates Zoledronic acid Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 26, 2015