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A Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency

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ClinicalTrials.gov Identifier: NCT02833610
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : October 5, 2018
Sponsor:
Collaborators:
Amgen
Emory University
University of Rochester
University Hospitals Cleveland Medical Center
Information provided by (Responsible Party):
Elizabeth O'Donnell, Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Denosumab Q4W Phase 2

Detailed Description:

This research study is a Phase II clinical trial. This study will assess the safety and tolerability of denosumab in Multiple Myeloma participants, by studying drug interactions with different parts of the body.

The FDA (the U.S. Food and Drug Administration) has not approved Denosumab for this specific disease but it has been approved denosumab for use in other cancers to treat cancer-related bone disease such as prostate and breast cancer.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Single-Arm Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency
Actual Study Start Date : August 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Denosumab

Arm Intervention/treatment
Experimental: Denosumab Injection
Patients will be administered Denosumab Q4W at a pre-determine dose for 12 cycles. Denosumab Q4W is administered by subcutaneous injection.
Drug: Denosumab Q4W
Other Names:
  • Xgeva
  • Prolia




Primary Outcome Measures :
  1. Percent Change Of sCTX Levels [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Percent Change In Bone Mineral Density [ Time Frame: 2 years ]
  2. Percent Change In uNTX Levels [ Time Frame: 2 years ]
  3. Subject Incidence Of Hypocalcemia [ Time Frame: 2 years ]
  4. Subject Incidence Of Occurrence Of Documented SRE At 12 Months [ Time Frame: 2 years ]
  5. Subject Incidence Of Adverse Events [ Time Frame: 2 years ]
  6. Percent Change In Bone Turnover Markers [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 0-3 lines of prior anti-myeloma therapy.
  • Subjects with reproductive potential must be willing to use, in combination with his/her partner, 2 highly effective methods of effective contraception or practice sexual abstinence throughout the study and continue for 5 months after the study duration. Subjects who are surgically sterile (e.g. history of bilateral tubal ligation, hysterectomy) or whose sexual partner is sterile (e.g. history of vasectomy) are not required to use additional contraceptive measures.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • 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
  • Subject is pregnant or breast feeding, or planning to become pregnant within 5 months after the end of treatment.
  • Female subject of child-bearing potential is not willing to use, in combination with her partner, 2 methods of highly effective contraception during treatment and for 5 months after the end of treatment.
  • Clinically significant hypersensitivity to denosumab 120 mg.
  • Known sensitivity to any of the products to be administered during the study (e.g. calcium, or vitamin D).
  • Subject is receiving or is less than 14 days since ending other experimental drug (no marketing authorization for any indication).
  • Any major medical or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02833610


Contacts
Contact: Elizabeth K O'Donnell, MD 617-724-4000 ekodonnell@partners.org

Locations
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Ajay Nooka, M.D.         
United States, Massachusetts
Massachusetts general Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Elizabeth K O'Donnell, MD    617-724-4000    ekodonnell@partners.org   
Principal Investigator: Elizabeth K O'Donnel, MD         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jacob Laubach, MD    617-632-4218    Jacobp_laubach@dfci.harvard.edu   
Mass General/North Shore Cancer Center Recruiting
Danvers, Massachusetts, United States, 01923
Contact: Andrew Yee, M.D.         
Newton Wellesley Hospital Recruiting
Newton, Massachusetts, United States, 02462
Contact: Omar Nadeem, M.D.         
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Brea Lipe, M.D.         
United States, Ohio
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Ehsan Malek, MD    216-844-8640      
Sponsors and Collaborators
Massachusetts General Hospital
Amgen
Emory University
University of Rochester
University Hospitals Cleveland Medical Center
Investigators
Principal Investigator: Elizabeth K O'Donnell, MD Massachusetts General Hospital

Responsible Party: Elizabeth O'Donnell, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02833610     History of Changes
Other Study ID Numbers: 15-571
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Elizabeth O'Donnell, Massachusetts General Hospital:
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Denosumab
Neoplasms, Plasma Cell
Renal Insufficiency
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Kidney Diseases
Urologic Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs