Multiple MyelomaPhase 2NCT02833610
A Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency
A Phase 2 study testing Denosumab Q4W in people with Multiple Myeloma, run by Massachusetts General Hospital at 7 sites in United States.
Trial summary
This research study is studying a possible therapy as a possible treatment for the consequences of Multiple Myeloma with renal insufficiency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Denosumab Q4W
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2016to 20 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Emory University Hospital
Atlanta, Georgia, 30322
Massachusetts general Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Mass General/North Shore Cancer Center
Danvers, Massachusetts, 01923
Newton Wellesley Hospital
Newton, Massachusetts, 02462
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: A Phase 2, Single-Arm Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency
This research study is studying a possible therapy as a possible treatment for the consequences of Multiple Myeloma with renal insufficiency.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- Denosumab Q4W
- Keywords
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denosumab Q4WDrug
Also called Xgeva, Prolia
| Study group | Role | What they receive |
|---|---|---|
| Denosumab Injection | Experimental | Patients will be administered Denosumab Q4W at a pre-determine dose for 12 cycles. Denosumab Q4W is administered by subcutaneous injection. Receives: Drug: Denosumab Q4W |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change Of sCTX Levels
Measured: 2 years
Secondary outcomes (6)
Percent Change In Bone Mineral Density
Measured: 2 years
Percent Change In uNTX Levels
Measured: 2 years
Subject Incidence Of Hypocalcemia
Measured: 2 years
Subject Incidence Of Occurrence Of Documented SRE At 12 Months
Measured: 2 years
Subject Incidence Of Adverse Events
Measured: 2 years
Percent Change In Bone Turnover Markers
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startAug 2016
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen, Emory University, University of Rochester, University Hospitals Cleveland Medical Center
- Responsible party
- Principal investigator, Andrew Yee, MD, Massachusetts General Hospital
- Investigators
- Elizabeth K O'Donnell, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833610
- Sponsor's protocol ID
- 15-571
- Status last verified
- Feb 2026
- First submitted
- 12 Jul 2016
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-Arm Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency
- ClinicalTrials.gov ID
- NCT02833610
- Acronym / sponsor ID
- 15-571
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Amgen, Emory University, University of Rochester, University Hospitals Cleveland Medical Center
- Study start
- Aug 2016 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Denosumab Injection | Experimental | Drug: Denosumab Q4WPatients will be administered Denosumab Q4W at a pre-determine dose for 12 cycles. Denosumab Q4W is administered by subcutaneous injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients with symptomatic MM as defined by IMWG requiring anti-myeloma therapy.
- 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
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Denosumab Q4WAlso: Xgeva, Prolia | Drug | Denosumab Injection |
Primary outcome
Percent Change Of sCTX Levels
Time frame: 2 years
6 secondary outcomes
Percent Change In Bone Mineral Density
Time frame: 2 years
Percent Change In uNTX Levels
Time frame: 2 years
Subject Incidence Of Hypocalcemia
Time frame: 2 years
Subject Incidence Of Occurrence Of Documented SRE At 12 Months
Time frame: 2 years
Subject Incidence Of Adverse Events
Time frame: 2 years
Percent Change In Bone Turnover Markers
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth K O'Donnell, MD principal investigator
Massachusetts General Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Denosumab Q4W in people with Multiple Myeloma, run by Massachusetts General Hospital at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change Of sCTX Levels (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.