A Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency

STATUS

Recruiting
End date

Oct 27, 2022
participants needed

55
sponsor

Massachusetts General Hospital

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Updated on 27 January 2022

See if I qualify

vasectomy

calcium

monoclonal antibodies

bone marrow procedure

monoclonal protein

bisphosphonate

serum calcium

plasmacytoma

Summary

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

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.

Details

Condition	Multiple Myeloma
Treatment	Denosumab Q4W
Clinical Study Identifier	NCT02833610
Sponsor	Massachusetts General Hospital
Last Modified on	27 January 2022

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Eligibility		Yes	No	Not Sure
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
	-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

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Step 3 Enroll in the clinical study

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Step 4 Get your study results

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A Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency