A Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency

NCT02833610 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 15-571
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 7

Brief Summary

This research study is studying a possible therapy as a possible treatment for the consequences of Multiple Myeloma with renal insufficiency.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Percent Change Of sCTX Levels

  2 years

Secondary Outcomes (6)

• Percent Change In Bone Mineral Density

  2 years

• Percent Change In uNTX Levels

  2 years

• Subject Incidence Of Hypocalcemia

  2 years

• Subject Incidence Of Occurrence Of Documented SRE At 12 Months

  2 years

• Subject Incidence Of Adverse Events

  2 years

Study Arms (1)

Denosumab Injection

EXPERIMENTAL

Patients will be administered Denosumab Q4W at a pre-determine dose for 12 cycles. Denosumab Q4W is administered by subcutaneous injection.

Drug: Denosumab Q4W

Interventions

Denosumab Q4W DRUG

Also known as: Xgeva, Prolia

Denosumab Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with symptomatic MM as defined by IMWG requiring anti-myeloma therapy.
• 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
• Creatinine clearance \< 30 mL/min, not eligible for bisphosphonate. Estimated glomerular filtration rate will be calculated using Cockcroft-Gault equation.
• Serum calcium or albumin-adjusted serum calcium ≥ 2.1 mmol/L (8.4 mg/dL) and ≤ 2.9 mmol/L (11.5 mg/dL) (Reference range 8.5-10.8 mg/dL)
• Able to tolerate daily supplementation of calcium and vitamin D
• Vitamin D level ≥ 30 ng/mL after repletion
• Participants must have normal organ as defined below:
• Total bilirubin ≤ 2.0 x ULN
• AST(SGOT) ≤2.5 × institutional upper limit of normal
• ALT(SGPT) ≤2.5 × institutional upper limit of normal
• Plan to receive anti-myeloma therapies.
• Age ≥ 18 years.
• ECOG performance status ≤ 2
• Life expectancy greater than 6 months

You may not qualify if:

• Prior administration of denosumab.
• Active IV bisphosphonate use in the last 3 months.
• POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
• Plasma cell leukemia.
• 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 during the course of study.
• Evidence of any of the following conditions per subject self-report or medical chart review
• Any prior invasive malignancy within 5 years of enrollment that may affect outcome of study
• Any non-invasive malignancy not treated with curative intent or with known active disease within 5 years before enrollment that may affect outcome of study
• Major surgery or significant traumatic injury occurring within 4 weeks before enrollment
• Active infection with Hepatitis B virus or Hepatitis C virus
• known infection with human immunodeficiency virus (HIV)
• Active infection requiring IV anti-infective therapy

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Amgen: collaborator
• Emory University: collaborator
• University of Rochester: collaborator
• University Hospitals Cleveland Medical Center: collaborator

Study Sites (7)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Massachusetts general Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Mass General/North Shore Cancer Center

Danvers, Massachusetts, 01923, United States

Location

Newton Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Elizabeth K O'Donnell, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 14, 2016
• Study Start: August 1, 2016
• Primary Completion: March 20, 2023
• Study Completion: March 20, 2023
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)