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

Status: Recruiting
Diagnosis: Multiple Myeloma
NCT ID: NCT01345019 (View complete trial on
DFCI Protocol ID: 12-355


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.


Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital/ North Shore Cancer Center, Brigham and Women's Hospital

Overall PI:
Noopur Raje, MD, Massachusetts General Hospital

Site-responsible Investigators:
Andrew Yee, MD, Massachusetts General Hospital
Jacob Laubach, MD, Dana-Farber Cancer Institute

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Kathleen Colson, 617-632-6303,

Eligibility 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
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