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Monoclonal Antibodies

Denosumab for Multiple Myeloma

Phase 2
Waitlist Available
Led By Brea Lipe
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG PS ≤1
Age ≥ 18 years
Must not have
Any history of IV bisphosphonate use prior to or during the study
Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 year
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial will test if a drug called denosumab is safe and effective in treating people with a condition called smoldering multiple myeloma, which could turn into the cancer multiple myeloma.

Who is the study for?
This trial is for adults over 18 with smoldering multiple myeloma (SMM) who meet specific health criteria, including normal organ function and a life expectancy of more than a year. They must be able to take daily calcium and vitamin D, have no history of certain bone treatments, and agree to use effective contraception.
What is being tested?
The study tests the safety and potential effectiveness of denosumab in reducing the risk of developing active multiple myeloma in patients with SMM. It will also assess how well participants tolerate this medication.
What are the potential side effects?
Denosumab may cause low calcium levels, skin rash, or infections. There's also a rare chance it could lead to jawbone problems (osteonecrosis), especially after dental procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active and can carry on all my pre-disease activities without restriction.
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I am 18 years old or older.
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I have been diagnosed with smoldering multiple myeloma.
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My organs are functioning normally.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have used IV bisphosphonates before or during the study.
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I have or had bone disease in my jaw.
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I take more than 10mg of prednisone or similar medication daily.
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I have had recent dental surgery that hasn't fully healed.
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I know the specific reason for my bone thinning or weakening.
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I need oral surgery or a tooth extraction due to a dental condition.
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I plan to undergo dental surgery while in the study.
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I have previously received denosumab treatment.
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I have symptoms from my multiple myeloma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Subjects With a Downgraded Risk of Progression of Smoldering Multiple Myeloma if the Risk Category Decreases.
Secondary study objectives
Proportion of Subjects With Change in Bone Mineral Density
Proportion of Subjects With Disease Progression to Multiple Myeloma
Proportion of Subjects With Progression Free Survival
+1 more

Side effects data

From 2022 Phase 4 trial • 37 Patients • NCT04026256
44%
joint pain
22%
nausea
22%
propagation of fracture at biopsy site
11%
dizziness
11%
rhinorrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Denosumab Only
Teriparatide Only
Denosumab and Teriparatide

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DenosumabExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Denosumab
FDA approved

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
869 Previous Clinical Trials
549,742 Total Patients Enrolled
11 Trials studying Multiple Myeloma
306 Patients Enrolled for Multiple Myeloma
AmgenIndustry Sponsor
1,435 Previous Clinical Trials
1,396,240 Total Patients Enrolled
97 Trials studying Multiple Myeloma
20,745 Patients Enrolled for Multiple Myeloma
Brea Lipe5.03 ReviewsPrincipal Investigator - University of Rochester Wilmot Cancer Center
University of Rochester
2 Previous Clinical Trials
55 Total Patients Enrolled
2 Trials studying Multiple Myeloma
55 Patients Enrolled for Multiple Myeloma

Media Library

Denosumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03839459 — Phase 2
Multiple Myeloma Research Study Groups: Denosumab
Multiple Myeloma Clinical Trial 2023: Denosumab Highlights & Side Effects. Trial Name: NCT03839459 — Phase 2
Denosumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03839459 — Phase 2
~3 spots leftby Nov 2025
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