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
Updated on 27 January 2022
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 IdentifierNCT02833610
SponsorMassachusetts General Hospital
Last Modified on27 January 2022

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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