A Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Nephrology / Urology, Oncology
Healthy:No
Age Range:18 - Any
Updated:10/7/2018
Start Date:August 2016
End Date:October 2023
Contact:Elizabeth K O'Donnell, MD
Email:ekodonnell@partners.org
Phone:617-724-4000

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A Phase 2, Single-Arm Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency

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

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.

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.
We found this trial at
7
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Elizabeth K O'Donnel, MD
Phone: 617-724-4000
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-4218
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
Phone: 216-844-8640
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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Danvers, Massachusetts 01923
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2014 Washington St
Newton, Massachusetts 02462
(617) 243-6000
Newton-Wellesley Hospital A comprehensive medical center located right in Newton on Washington Street, Newton-Wellesley Hospital...
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Newton, MA
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