Multiple MyelomaPhase 2DEFENCENCT03792763
Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients
A Phase 2 study testing Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA] in people with Multiple Myeloma, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 10 sites in 3 countries.
Trial summary
This is a randomized, 2-arm phase II, placebo-controlled, multi-center study, where the investigators aim to evaluate whether the reported benefits of denosumab, delay of SRE and decrease in myeloma growth promotion, reduce the risk of progression of high-risk SMM and of early 'SLiM CRAB' myeloma into active… 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 120 MG/1.7 ML Subcutaneous Solution [XGEVA]
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 30 Sep 2019to 14 Sep 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
- Age ≥ 18 years
- Able to provide written informed consent in accordance with federal, local, and institutional guidelines
- Must meet criteria of high-risk smoldering MM or early "SLiM CRAB" MM based on the criteria described below:
- High-risk SMM is defined here according to the revised Mayo Clinical criteria (2 out of 3 criteria must be fulfilled):
- Bone marrow clonal plasma cells > 20%
- Serum M protein > 2.0g/dL
Show all 13Show fewer
- Serum-free light chain ratio > 20, measured with "Binding site Kit"
- Early 'SLiM CRAB' multiple myeloma
- Patients must present with only one of the following features
- Bone marrow clonal plasma cells ≥ 60%, or
- Serum FLC ratio ≥ 100 (kappa-LC leading) or ≤ 0.01 (lambda-LC leading), measured with "Binding site Kit", or
- >1 Focal bone lesion of ≥5mm (not associated with osteolysis, detected by PET-CT or whole-body low-dose CT (WBLDCT))
- Time from diagnosis of high-risk SMM or SLIM CRAB positive, early MM to study enrollment: <5 years
Who cannot join
- ECOG >3
- Active, symptomatic MM (fulfilling CRAB-criteria)
- Non-secretory MM, extramedullary plasmacytoma, plasma cell leukemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- MGUS
- Hypocalcemia (can be corrected by drug intervention before start of treatment)
- Second malignancy within the past 5 years except:
Show all 28Show fewer
- Adequately treated basal cell or squamous cell skin cancer
- Carcinoma in situ of the cervix
- Prostate cancer Gleason score ≤ 6 with stable prostate-specific antigen (PSA over 12 months)
- Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins)
- Treated medullary or papillary thyroid cancer
- Similar condition with an expectation of > 95% five-year disease-free survival
- Active infection within the 14 days prior to randomization requiring systemic antibiotics and/or antiviral therapy
- Patients with known active or latent tuberculosis
- Known human immunodeficiency virus (HIV) seropositivity or active hepatitis C or hepatitis B infection (subjects with past hepatitis B virus [HBV] infection or resolved HBV infection defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test are eligible; subjects positive for hepatitis C virus [HCV] antibody are eligible only if polymerase chain reaction [PCR] is negative for HCV RNA.)
- Participation in another interventional study within the 28 days prior to randomization
- Any other clinically significant medical disease or social condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent, be compliant with study procedures, or provide accurate information.
- Prior administration of denosumab
- Prior exposure to any experimental or approved anti-myeloma agent
- Use of oral bisphosphonates with a cumulative exposure of more than 1 year (washout period for allowed bisphosphonate exposure 1 month)
- More than 1 previous dose of IV bisphosphonate or teriparatide administration (washout period for allowed bisphosphonate exposure 1 month)
- Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
- Active dental or jaw condition which requires oral surgery, including tooth extraction
- Subject is pregnant or breastfeeding, or planning to become pregnant within 7 months after the end of treatment
- Female subject of childbearing potential is not willing to use, in combination with her partner, a highly effective and in addition an effective method of contraception during treatment and for 5 months after the end of treatment
- Known sensitivity to denosumab (including all components of the formulation) or any of the products to be administered during the study (eg, mammalian derived products, calcium, or vitamin D)
- Subject is receiving or is less than 30 days since ending other experimental devices or drugs (no marketing authorization for any indication).
- Subject will not be available for follow-up assessment
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Austria8 sites
Medizinische Universitaet Graz, Univ.-Klinik f. Innere Medizin, Onkologie
Graz, A-8036
Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V Hämatologie und Onkologie
Innsbruck, 6020
LKH Hochsteiermark, Standort Leoben, Abteilung für Innere Medizin und Hämatologie und internistische Onkologie
Leoben, A-8700
Kepler Universitaetsklinikum Klinik f. Interne 3, Med Campus III
Linz, 4021
BHS Linz: Interne I: Internistische Onkologie, Hämatologie und Gastroenterologie
Linz, A-4020
IIIrd Medical Department, Private Medical University Hospital Salzburg
Salzburg, State of Salzburg, 5020
Hanusch Krankenhaus der Österreichischen Gesundheitskasse, 3. Med. Abteilung
Vienna, 1140
Krankenhaus St. Vinzenz Zams, Innere Medizin, Internistische Onkologie und Hämatologie
Zams, 6511
Germany1 site
University Hospital Würzburg, Department of Internal Medicine 2
Würzburg, 97080
Israel1 site
Tel Aviv Sourasky Medical Center, Department of Hematology,
Tel Aviv, 6423906
About this study
Official title: Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients- a Randomized, Placebo Controlled Phase II Trial "DEFENCE" (DEnosumab For the rEductioN of the Smoldering Myeloma transformatioN inCidence ratE)
This is a randomized, 2-arm phase II, placebo-controlled, multi-center study, where the investigators aim to evaluate whether the reported benefits of denosumab, delay of SRE and decrease in myeloma growth promotion, reduce the risk of progression of high-risk SMM and of early 'SLiM CRAB' myeloma into active, symptomatic CRAB positive myeloma or serological progression. In addition, tolerability of long-term treatment will be assessed.
Read the detailed description
The aim of this study is to evaluate whether the transition of early Multiple Myeloma (High Risk Smouldering Multiple Myeloma SMM or "Ultra High Risk" SMM) or SLiM CRAB positive multiple myeloma to a symptomatic multiple myeloma (MM) can be reduced or delayed by the administration of denosumab.
With the exception of clinical studies, there are currently no standardized treatment options for SMM. Ultra-high risk SMM is already part of early active myeloma and is therefore in some cases treated according to a standard myeloma protocol (Revlimid-Dexamethasone, Velcade melphalan prednisone, melphalan prednisone thalidomide, or others). However, most practitioners recommend a wait-and-see strategy, since depending on the initial situation within two years only 58-95% of patients develop an 'active' MM and 5-42% of the patients had a stable disease and therefore do not necessarily have to be treated immediately.
Denosumab is a human monoclonal antibody (IgG2) which binds to RANKL with high affinity and specificity. RANKL (receptor activator of NF-κB Ligand) is a protein that is responsible for the formation, function and survival of osteoclasts (cell type responsible for bone resorption) Increased osteoclast activity, stimulated by RANKL, is a key mediator of the bone resorption in bone metastases and MM. Thus the activity of denosumab is resulting in a reduced number and function of osteoclasts and thus decreases the bone resorption and tumor-induced bone destruction.
After an initial phase of about 14 days (screening), the patients will be randomized 1:1 in one of the two study groups (arm A: denosumab or arm B: placebo). The study is double-blinded. The planned duration of therapy is 3 years. Patients receive denosumab or placebo every 4 weeks for 6 months, then every 3 months until a total of 3 years or progression.
After completion of the therapy, an observation and follow-up phase is carried out with patient visits every 3 months until the end of the treatment.
- Conditions
- Multiple Myeloma
- Being tested
- Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA], Placebo 1.7 ml Subcutaneous Solution
- Keywords
- early multiple myeloma, smoldering multiple myeloma, SLiM CRAB, denosumab, Austrian Study Group of Medical Tumour Therapy (AGMT), high risk smoldering myeloma
- Medical subject headings
- Multiple Myeloma, Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]Drug
Administration every 4 weeks (Q4W) for 6 months then every 3 months (Q3M) for a total of 3 years or until progression to active, symptomatic MM
Placebo 1.7 ml Subcutaneous SolutionDrug
Administration every 4 weeks (Q4W) for 6 months then every 3 months (Q3M) for a total of 3 years or until progression to active, symptomatic MM
| Study group | Role | What they receive |
|---|---|---|
| Arm A, denosumab | Experimental | Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]
Every 4 weeks (Q4W) for 6 months then every 3 months (Q3M) for a total of 3 years or until progression to active, symptomatic MM
Calcilac 500 mg/400 I.E. (Calcium/Vitamin D3) Concomitant medication, oral, 1 chewable tablet / day Receives: Drug: Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA] |
| Arm B, placebo | Placebo comparator | Placebo 1.7 ml Subcutaneous Solution
SC every 4 weeks (Q4W) for 6 months then every 3 months (Q3M) for a total of 3 years or until progression to active, symptomatic MM
Calcilac 500 mg/400 I.E. (Calcium/Vitamin D3) Concomitant medication, oral, 1 chewable tablet / day Receives: Drug: Placebo 1.7 ml Subcutaneous Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression
Time from randomization to transformation to symptomatic, active MM (defined as progression to active multiple myeloma according to IMWG diagnosis criteria 2014) or progression of disease according to IMWG response criteria 2016
Measured: 78 months (the first 6 cycles are 28 days, thereafter each cycle is 3 months for a maximum of 36 months)
Secondary outcomes (5)
Percentage of patients transforming in 3 years
Percentage of patients with high-risk SMM and early 'slim CRAB' positive MM transforming to CRAB positive multiple myeloma and/or developing serological progression (as defined by IMWG criteria 2016 for MM) within 3 years
Measured: 36 months (the first 6 cycles are 28 days, thereafter each cycle is 3 months)
Overall survival
To determine the overall survival of patients receiving either denosumab or placebo
Measured: 78 months (the first 6 cycles are 28 days, thereafter each cycle is 3 months for a maximum of 36 months)
Time to first skeletal-related event
To determine the time to first skeletal-related event for patients receiving either denosumab or placebo. • Imaging: low dose wbCT (details will be described in a separate guidance document) or PET-CT mandatory
Measured: 78 months (baseline and every 6 months thereafter until progression or maximum of 3 years).
Incidence of bone lesions as MM defining events
To determine the incidence of bone lesions as MM defining events. • Imaging: low dose wbCT (details will be described in a separate guidance document) or PET-CT mandatory.
Measured: 78 months (baseline and every 6 months thereafter until progression or maximum of 3 years).
Time to first anti-myeloma treatment
To determine the time to first anti-myeloma treatment for patients receiving either denosumab or placebo
Measured: 78 months (the first 6 cycles are 28 days, thereafter each cycle is 3 months for a maximum of 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start30 Sep 2019
- Primary completion14 Sep 2023
- Study completion14 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo controlled, randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen, Assign Data Management and Biostatistics GmbH
- Responsible party
- Sponsor
- Investigators
- Heinz Ludwig, MD, Study director, Wilheminenspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792763
- Sponsor's protocol ID
- AGMT_MM-3
- Acronym
- DEFENCE
- Status last verified
- Feb 2025
- First submitted
- 21 Dec 2018
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lakshman A, Rajkumar SV, Buadi FK, Binder M, Gertz MA, Lacy MQ, Dispenzieri A, Dingli D, Fonder AL, Hayman SR, Hobbs MA, Gonsalves WI, Hwa YL, Kapoor P, Leung N, Go RS, Lin Y, Kourelis TV, Warsame R, Lust JA, Russell SJ, Zeldenrust SR, Kyle RA, Kumar SK. Risk stratification of smoldering multiple myeloma incorporating revised IMWG diagnostic criteria. Blood Cancer J. 2018 Jun 12;8(6):59. doi: 10.1038/s41408-018-0077-4.
PubMed 29895887Mateos MV, Landgren O. MGUS and Smoldering Multiple Myeloma: Diagnosis and Epidemiology. Cancer Treat Res. 2016;169:3-12. doi: 10.1007/978-3-319-40320-5_1.
PubMed 27696254
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients- a Randomized, Placebo Controlled Phase II Trial "DEFENCE" (DEnosumab For the rEductioN of the Smoldering Myeloma transformatioN inCidence ratE)
- ClinicalTrials.gov ID
- NCT03792763
- Acronym / sponsor ID
- DEFENCE / AGMT_MM-3
- Conditions
- Multiple Myeloma
- Keywords
- early multiple myeloma, smoldering multiple myeloma, SLiM CRAB, denosumab, Austrian Study Group of Medical Tumour Therapy (AGMT), high risk smoldering myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese TumortherapieUniversity, hospital or other
- Collaborators
- Amgen, Assign Data Management and Biostatistics GmbH
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 3 Jan 2019 (actual)
- 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 is a randomized, 2-arm phase II, placebo-controlled, multi-center study, where the investigators aim to evaluate whether the reported benefits of denosumab, delay of SRE and decrease in myeloma growth promotion, reduce the risk of progression of high-risk SMM and of early 'SLiM CRAB' myeloma into active, symptomatic CRAB positive myeloma or serological progression. In addition, tolerability of long-term treatment will be assessed.
Detailed description
The aim of this study is to evaluate whether the transition of early Multiple Myeloma (High Risk Smouldering Multiple Myeloma SMM or "Ultra High Risk" SMM) or SLiM CRAB positive multiple myeloma to a symptomatic multiple myeloma (MM) can be reduced or delayed by the administration of denosumab.
With the exception of clinical studies, there are currently no standardized treatment options for SMM. Ultra-high risk SMM is already part of early active myeloma and is therefore in some cases treated according to a standard myeloma protocol (Revlimid-Dexamethasone, Velcade melphalan prednisone, melphalan prednisone thalidomide, or others). However, most practitioners recommend a wait-and-see strategy, since depending on the initial situation within two years only 58-95% of patients develop an 'active' MM and 5-42% of the patients had a stable disease and therefore do not necessarily have to be treated immediately.
Denosumab is a human monoclonal antibody (IgG2) which binds to RANKL with high affinity and specificity. RANKL (receptor activator of NF-κB Ligand) is a protein that is responsible for the formation, function and survival of osteoclasts (cell type responsible for bone resorption) Increased osteoclast activity, stimulated by RANKL, is a key mediator of the bone resorption in bone metastases and MM. Thus the activity of denosumab is resulting in a reduced number and function of osteoclasts and thus decreases the bone resorption and tumor-induced bone destruction.
After an initial phase of about 14 days (screening), the patients will be randomized 1:1 in one of the two study groups (arm A: denosumab or arm B: placebo). The study is double-blinded. The planned duration of therapy is 3 years. Patients receive denosumab or placebo every 4 weeks for 6 months, then every 3 months until a total of 3 years or progression.
After completion of the therapy, an observation and follow-up phase is carried out with patient visits every 3 months until the end of the treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo controlled, randomized
| Arm | Type | Receives |
|---|---|---|
| Arm A, denosumab | Experimental | Drug: Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA] Every 4 weeks (Q4W) for 6 months then every 3 months (Q3M) for a total of 3 years or until progression to active, symptomatic MM Calcilac 500 mg/400 I.E. (Calcium/Vitamin D3) Concomitant medication, oral, 1 chewable tablet / day |
| Arm B, placebo | Placebo comparator | Drug: Placebo 1.7 ml Subcutaneous SolutionPlacebo 1.7 ml Subcutaneous Solution SC every 4 weeks (Q4W) for 6 months then every 3 months (Q3M) for a total of 3 years or until progression to active, symptomatic MM Calcilac 500 mg/400 I.E. (Calcium/Vitamin D3) Concomitant medication, oral, 1 chewable tablet / day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 18 years
- Able to provide written informed consent in accordance with federal, local, and institutional guidelines
- Must meet criteria of high-risk smoldering MM or early "SLiM CRAB" MM based on the criteria described below:
- Time from diagnosis of high-risk SMM or SLIM CRAB positive, early MM to study enrollment: <5 years
Key exclusion criteria (28 listed)
- ECOG >3
- Active, symptomatic MM (fulfilling CRAB-criteria)
- Non-secretory MM, extramedullary plasmacytoma, plasma cell leukemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- MGUS
- Hypocalcemia (can be corrected by drug intervention before start of treatment)
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 120 MG/1.7 ML Subcutaneous Solution [XGEVA]Administration every 4 weeks (Q4W) for 6 months then every 3 months (Q3M) for a total of 3 years or until progression to active, symptomatic MM | Drug | Arm A, denosumab |
| Placebo 1.7 ml Subcutaneous SolutionAdministration every 4 weeks (Q4W) for 6 months then every 3 months (Q3M) for a total of 3 years or until progression to active, symptomatic MM | Drug | Arm B, placebo |
Primary outcome
Time to progression
Time frame: 78 months (the first 6 cycles are 28 days, thereafter each cycle is 3 months for a maximum of 36 months)
Time from randomization to transformation to symptomatic, active MM (defined as progression to active multiple myeloma according to IMWG diagnosis criteria 2014) or progression of disease according to IMWG response criteria 2016
5 secondary outcomes
Percentage of patients transforming in 3 years
Time frame: 36 months (the first 6 cycles are 28 days, thereafter each cycle is 3 months)
Overall survival
Time frame: 78 months (the first 6 cycles are 28 days, thereafter each cycle is 3 months for a maximum of 36 months)
Time to first skeletal-related event
Time frame: 78 months (baseline and every 6 months thereafter until progression or maximum of 3 years).
Incidence of bone lesions as MM defining events
Time frame: 78 months (baseline and every 6 months thereafter until progression or maximum of 3 years).
Time to first anti-myeloma treatment
Time frame: 78 months (the first 6 cycles are 28 days, thereafter each cycle is 3 months for a maximum of 36 months)
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 11 Feb 2025.
- Background: PubMed 29895887Lakshman A, Rajkumar SV, Buadi FK, Binder M, Gertz MA, Lacy MQ, Dispenzieri A, Dingli D, Fonder AL, Hayman SR, Hobbs MA, Gonsalves WI, Hwa YL, Kapoor P, Leung N, Go RS, Lin Y, Kourelis TV, Warsame R, Lust JA, Russell SJ, Zeldenrust SR, Kyle RA, Kumar SK. Risk stratification of smoldering multiple myeloma incorporating revised IMWG diagnostic criteria. Blood Cancer J. 2018 Jun 12;8(6):59. doi: 10.1038/s41408-018-0077-4.
- Background: PubMed 27696254Mateos MV, Landgren O. MGUS and Smoldering Multiple Myeloma: Diagnosis and Epidemiology. Cancer Treat Res. 2016;169:3-12. doi: 10.1007/978-3-319-40320-5_1.
- Description sponsorLink provided by the sponsor.
- 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.
Heinz Ludwig, MD study director
Wilheminenspital
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA] in people with Multiple Myeloma, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 10 sites in 3 countries.
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 13 inclusion and 28 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 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Austria, Germany, Israel. 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. Some participants in this study may receive a placebo. 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?
Time to progression (time frame: 78 months (the first 6 cycles are 28 days, thereafter each cycle is 3 months for a maximum of 36 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03792763, which also lists 2 linked publications.
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 11 Feb 2025.