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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 am willing and able to follow the study's treatment and visit schedule.
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I have been diagnosed with smoldering multiple myeloma.
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I can take daily calcium and vitamin D supplements without issues.
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My organs are functioning normally.
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I am of any ethnicity or racial background.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Subjects With a Downgraded Risk of Progression of Smoldering Multiple Myeloma if the Risk Category Decreases.
Secondary outcome measures
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

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
833 Previous Clinical Trials
518,124 Total Patients Enrolled
11 Trials studying Multiple Myeloma
306 Patients Enrolled for Multiple Myeloma
AmgenIndustry Sponsor
1,355 Previous Clinical Trials
1,384,051 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,726 Patients Enrolled for Multiple Myeloma
Brea Lipe5.03 ReviewsPrincipal Investigator - University of Rochester Wilmot Cancer Center
University of Rochester
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Multiple Myeloma
15 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

When was Denosumab cleared by the FDA?

"Since Phase 2 trials only have data supporting safety and no data regarding efficacy, denosumab was given a score of 2."

Answered by AI

Yes, can you please tell us about some of the other research studies that have used Denosumab?

"Denosumab is being researched in 49 studies, with 13 of those research projects at Phase 3. The large majority of these trials are based in Nedlands, Western Australia; however, there are 539 locations running these Denosumab trials globally."

Answered by AI

Are we still enrolling people in this experiment?

"The clinical trial in question is no longer recruiting patients, based on the information available on clinicaltrials.gov. This specific study was posted on April 19th, 2019 and updated for the last time on October 3rd, 2022. There are 877 other trials currently enrolling patients."

Answered by AI

Could you explain what conditions are helped by Denosumab?

"Denosumab is used to target bones and bone marrow. It can also help with other issues such as skeletally mature, androgens, malignant neoplasms."

Answered by AI

How many people are being asked to participate in this research project?

"This trial is not admitting patients at the moment. The most recent update was on October 3rd, 2022 and it was first posted April 19th, 2019. However, there are 828 other trials for smoldering multiple myeloma and 49 involving Denosumab that are currently enrolling patients."

Answered by AI
~3 spots leftby Mar 2025