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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 : May 27, 2019
Sponsor:
Collaborators:
Amgen
Emory University
University of Rochester
University Hospitals Cleveland Medical Center
Information provided by (Responsible Party):
Elizabeth O'Donnell, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE July 12, 2016
First Posted Date  ICMJE July 14, 2016
Last Update Posted Date May 27, 2019
Actual Study Start Date  ICMJE August 2016
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
Percent Change Of sCTX Levels [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02833610 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
  • Percent Change In Bone Mineral Density [ Time Frame: 2 years ]
  • Percent Change In uNTX Levels [ Time Frame: 2 years ]
  • Subject Incidence Of Hypocalcemia [ Time Frame: 2 years ]
  • Subject Incidence Of Occurrence Of Documented SRE At 12 Months [ Time Frame: 2 years ]
  • Subject Incidence Of Adverse Events [ Time Frame: 2 years ]
  • Percent Change In Bone Turnover Markers [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency
Official Title  ICMJE A Phase 2, Single-Arm Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency
Brief Summary This research study is studying a possible therapy as a possible treatment for the consequences of Multiple Myeloma with renal insufficiency.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE Drug: Denosumab Q4W
Other Names:
  • Xgeva
  • Prolia
Study Arms  ICMJE Experimental: Denosumab Injection
Patients will be administered Denosumab Q4W at a pre-determine dose for 12 cycles. Denosumab Q4W is administered by subcutaneous injection.
Intervention: Drug: Denosumab Q4W
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 13, 2016)
55
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elizabeth K O'Donnell, MD 617-724-4000 ekodonnell@partners.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02833610
Other Study ID Numbers  ICMJE 15-571
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Elizabeth O'Donnell, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE
  • Amgen
  • Emory University
  • University of Rochester
  • University Hospitals Cleveland Medical Center
Investigators  ICMJE
Principal Investigator: Elizabeth K O'Donnell, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP