Clinical Trials /

A Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency

NCT02833610

Description:

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

Related Conditions:
  • Multiple Myeloma
  • Plasmacytoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency
  • Official Title: A Phase 2, Single-Arm Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency

Clinical Trial IDs

  • ORG STUDY ID: 15-571
  • NCT ID: NCT02833610

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
Denosumab Q4WXgeva, ProliaDenosumab Injection

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Denosumab InjectionExperimentalPatients will be administered Denosumab Q4W at a pre-determine dose for 12 cycles. Denosumab Q4W is administered by subcutaneous injection.
  • Denosumab Q4W

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percent Change Of sCTX Levels
Time Frame:2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Percent Change In Bone Mineral Density
Time Frame:2 years
Safety Issue:
Description:
Measure:Percent Change In uNTX Levels
Time Frame:2 years
Safety Issue:
Description:
Measure:Subject Incidence Of Hypocalcemia
Time Frame:2 years
Safety Issue:
Description:
Measure:Subject Incidence Of Occurrence Of Documented SRE At 12 Months
Time Frame:2 years
Safety Issue:
Description:
Measure:Subject Incidence Of Adverse Events
Time Frame:2 years
Safety Issue:
Description:
Measure:Percent Change In Bone Turnover Markers
Time Frame:2 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Massachusetts General Hospital

Trial Keywords

  • Multiple Myeloma

Last Updated

November 24, 2019