Multiple MyelomaPhase 1/2CPDNCT02185820
Phase I/II Study of Carfilzomib, Pomalidomide and Dexamethasone in Relapsed And/Or Refractory Multiple Myeloma Patients (CPD)
A Phase 1/2 study testing Carfilzomib, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by European Myeloma Network B.V. at 1 site in Italy.
Trial summary
This protocol is a phase I/II multicenter study designed to assess the safety and the efficacy of the proposed combinations in relapsed and/or refractory Multiple Myeloma (MM) patients. 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?
- Carfilzomib, Pomalidomide and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2014to Jan 2023
- Phase
- Phase 1/2
- 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. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) for the duration of the study.
- Patients who are primary refractory or relapsed/refractory to Lenalidomide. Subjects must have been received at least 2 consecutive cycles of a prior treatment that include Lenalidomide alone or in combination.
- Subject must be primary refractory or relapsed/refractory to Lenalidomide, defined as: 1) never achieved any response better than progressive disease (PD) to any Lenalidomide-containing regimen; 2) documented disease progression during or within 60 days of completing their last myeloma Lenalidomide-containing regimen.
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- Both relapsed and/or refractory to Bortezomib and naive to Bortezomib patients can be enrolled.
- Patient has measurable disease, defined as follows: any quantifiable serum monoclonal protein value (generally, but not necessarily, ≥ 0.5 g/dL of M-protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours. For patients with oligo or non-secretory MM, it is required that they have measurable plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan) or an abnormal free light chain ratio (n.v.: 0.26-1.65). We anticipate that less than 10% of patients admitted to this study will be oligo- or non-secretory MM with free light chains only in order to maximize interpretation of benefit results.
- Patient has a Karnofsky performance status ≥60%. Patient has a life-expectancy >3 months.
- Patient has the following laboratory values within 14 days before Baseline (day 1 of the Cycle 1, before study drug administration):
- Platelet count ≥ 50 x 109/L (≥ 30 x 109/L if myeloma involvement in the bone marrow is > 50%) within 14 days prior to drug administration).
- Hemoglobin ≥ 8 g/dL (80 g/L) within 14 days prior to enrollment (subjects may be receiving red blood cell [RBC] transfusions in accordance with institutional guidelines).
- Absolute neutrophil count (ANC) ≥ 1 x 109/L without the use of growth factors. Corrected serum calcium ≤14 mg/dL (3.5 mmol/L) Alanine transaminase (ALT): ≤ 3.5 x the ULN. Total bilirubin: ≤ 2 x the ULN. Calculated or measured creatinine clearance ≥ 45 mL/min.
Who cannot join
- Newly diagnosed myeloma patients. Patient with non-secretory MM, unless serum free light chains are present and the ratio is abnormal.
- Pregnant or lactating females. Major surgery within 21 days prior to enrollment. Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to enrolment.
- Patient has active infectious hepatitis type A, B or C or HIV. Unstable angina or myocardial infarction within 4 months prior to enrollment, NYHA Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker.
- Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment.
- Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to enrollment.
- Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib).
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- Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to pre-existing pulmonary or cardiac impairment.
- Subject with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to baseline.
- Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.
- Nonhematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dipartimento di Biotecnologie Molecolari e Scienze per la Salute
Torino, 10126
About this study
Official title: A MULTICENTER, OPEN LABEL PHASE I/II STUDY OF CARFILZOMIB, POMALIDOMIDE AND DEXAMETHASONE IN RELAPSED AND/OR REFRACTORY MULTIPLE MYELOMA (MM) PATIENTS
This protocol is a phase I/II multicenter study designed to assess the safety and the efficacy of the proposed combinations in relapsed and/or refractory Multiple Myeloma (MM) patients.
Read the detailed description
TREATMENT PERIOD Patients will start the salvage treatment with CPd, as soon as the screening visits of the pre-treatment period have been terminated. Patients will receive 8 CPd cycles.
PHASE I
In the phase I part of the study, the following dose levels of pomalidomide will be studied with a constant dose of dexamethasone and carfilzomib:
Level -1 Carfilzomib = 20 mg/m2 IV once daily on days 1 of cycle 1 only followed by 27 mg/m2 days 8, 15 in cycle 1, then for all subsequent doses 27 mg/m2 IV once daily on days 1, 8, 15 followed by 13-day rest period (day 16 through 28).
Pomalidomide = 4 mg daily on days 1 - 21 every 28 days. Dexamethasone = 20 mg on days 1, 8, 15, 22 every 28 days. Level 0 (starting dose) Carfilzomib = 20 mg/m2 IV once daily on days 1 of cycle 1 only followed by 36 mg/m2 days 8, 15 in cycle 1, then for all subsequent doses 36 mg/m2 IV once daily on days 1, 8, 15 followed by 13-day rest period (day 16 through 28).
Pomalidomide = 4 mg daily on days 1 - 21 every 28 days. Dexamethasone = 20 mg on days 1, 8, 15, 22 every 28 days. Level +1 Carfilzomib = 20 mg/m2 IV once daily on days 1 of cycle 1 only followed by 45 mg/ m2 days 8, 15 in cycle 1, then for all subsequent doses 45 mg/m2 IV once daily on days 1, 8, 15 followed by 13-day rest period (day 16 through 28).
Pomalidomide = 4 mg daily on days 1 - 21 every 28 days. Dexamethasone = 20 mg on days 1, 8, 15, 22 every 28 days. Level +2 Carfilzomib = 20 mg/m2 IV once daily on days 1 of cycle 1 only followed by 56 mg/m2 days 8, 15 in cycle 1, then for all subsequent doses 56 mg/m2 IV once daily on days 1, 8, 15 followed by 13-day rest period (day 16 through 28).
Pomalidomide = 4 mg daily on days 1 - 21 every 28 days. Dexamethasone = 20 mg on days 1, 8, 15, 22 every 28 days. Patients will be observed during the first cycle of therapy for the assessment of side effects and observation of DLTs.
Dose escalation will proceed as follows:
3 patients will be entered at dose level 0. If none of the 3 experience DLT, dose escalation will continue. If one of three patients experience DLT, three additional patients will be added to this cohort (max 6).
If two of three patients experience a DLT at any given dose, the MTD will have been exceeded and the MTD will be the preceding dose at which < one of 6 patients experienced a DLT.
If no further patients experience DLT (1 of 6) dose escalation will continue. If 2 patients experience DLT (2 of 6) the MTD will have been exceeded and the MTD will be the previous dose at which <1 patient of 6 experienced DLT.
The phase I of the study will end once the MTD has been defined.
PHASE II The phase II of the study will start after the MTD has been defined in the phase I of the study. The dose used to treat patients in the phase II will be the MTD defined in the phase I of the study.
In the second part of the study, the MTD of the association CPd (or in absence of any MTD observed) the doses of dose level 3 (maximum per protocol dose) will be administered to a total of 45 consecutive patients in order to assess response rate and clinical efficacy.
THE PHASE 2 OF THE STUDY WILL START ONLY AFTER THE ANALYSIS OF THE PHASE 1 RESULTS AND THE RELEVANT STUDY REPORT.
MANTEINANCE PERIOD
At the end of 8 courses, maintenance phase will start. Patients will receive:
Carfilzomib = at the MTD achieved in the phase I of the study on days 1, 8, 15 in 28-days cycles.
Pomalidomide = 4 mg daily on days 1 - 21 every 28 days. Dexamethasone = 20 mg on days 1, 8, 15, 22. Patients will be stopped at PD or intolerance. For the maintenance period a continuous assessment of the toxicity and tolerability profile of the CPd combination could permit to the Investigators to continue the treatment using Pomalidomide or Carfilzomib alone according to the dose modification plan.
- Conditions
- Multiple Myeloma
- Being tested
- Carfilzomib, Pomalidomide, Dexamethasone
- Keywords
- Multiple myeloma, Relapsed and/or refractory, CPD
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarfilzomibDrug
PomalidomideDrug
DexamethasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment schedule for 8 cycles of induction:
Carfilzomib = 20 mg/m2 IV once daily on days 1 of cycle 1 only followed by 27/36/45/56 mg/m2 days 8, 15 in cycle 1, then for all subsequent doses 27/36/45/56 mg/m2 IV once daily on days 1, 8, 15 followed by 13-day rest period (day 16 through 28).
Pomalidomide = 4 mg daily on days 1 - 21 every 28 days. Dexamethasone = 20 mg on days 1, 8, 15, 22 every 28 days.
Treatment schedule for maintenance until progression or intolerance:
Carfilzomib = at the MTD achieved in the phase I of the study on days 1, 8, 15 in 28-days cycles.
Pomalidomide = 4 mg daily on days 1 - 21 every 28 days. Dexamethasone = 20 mg on days 1, 8, 15, 22. Receives: Drug: Carfilzomib; Drug: Pomalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
The dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of carfilzomib, pomalidomide and dexamethasone (CPd) association.
Measured: 1 year
Partial response
Determine the rate of partial response (PR) with the CPd association: a PR rate of 25% (p0) is considered not promising (H0) and a 45% (p1) as interesting.
Measured: 3 years
Secondary outcomes (8)
Toxicities
Less than 30% of patients presenting the following toxicities: grade 4 neutropenia lasting > 1 week, any grade 4 hematological toxicities except neutropenia, any > grade 3 extra-hematologic toxicities.
Measured: 3 years
PFS
Determine the progression-free survival (PFS).
Measured: 3 years
TTP
Determine the time to progression (TTP).
Measured: 3 years
DFS
Determine the disease free survival (DFS).
Measured: 3 years
DOR
Determine the duration of response (DOR).
Measured: 3 years
TTNT
Determine the time to next therapy (TTNT).
Measured: 3 years
OS
Determine the overall survival (OS).
Measured: 3 years
Tumor response and survival
Determine whether tumor response and survival might significantly change in particular subgroups of patients defined on prognostic factors (β2-microglobulin, C-reactive protein (CRP), FISH).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2015
- Study completionJan 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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Myeloma Network B.V.
- Sponsor type
- Research network
- Collaborators
- University of Turin, Italy
- Responsible party
- Sponsor
- Investigators
- Sara Bringhen, MD, Principal investigator, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185820
- Sponsor's protocol ID
- EMN07/IST-CAR-538
- Acronym
- CPD
- Status last verified
- Jun 2023
- First submitted
- 7 Jul 2014
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A MULTICENTER, OPEN LABEL PHASE I/II STUDY OF CARFILZOMIB, POMALIDOMIDE AND DEXAMETHASONE IN RELAPSED AND/OR REFRACTORY MULTIPLE MYELOMA (MM) PATIENTS
- ClinicalTrials.gov ID
- NCT02185820
- Acronym / sponsor ID
- CPD / EMN07/IST-CAR-538
- Conditions
- Multiple Myeloma
- Keywords
- Multiple myeloma, Relapsed and/or refractory, CPD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- European Myeloma Network B.V.Research network
- Collaborators
- University of Turin, Italy
- Study start
- Jun 2014 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jan 2023 (actual)
- First posted
- 10 Jul 2014 (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 protocol is a phase I/II multicenter study designed to assess the safety and the efficacy of the proposed combinations in relapsed and/or refractory Multiple Myeloma (MM) patients.
Detailed description
TREATMENT PERIOD Patients will start the salvage treatment with CPd, as soon as the screening visits of the pre-treatment period have been terminated. Patients will receive 8 CPd cycles.
PHASE I
In the phase I part of the study, the following dose levels of pomalidomide will be studied with a constant dose of dexamethasone and carfilzomib:
Level -1 Carfilzomib = 20 mg/m2 IV once daily on days 1 of cycle 1 only followed by 27 mg/m2 days 8, 15 in cycle 1, then for all subsequent doses 27 mg/m2 IV once daily on days 1, 8, 15 followed by 13-day rest period (day 16 through 28).
Pomalidomide = 4 mg daily on days 1 - 21 every 28 days. Dexamethasone = 20 mg on days 1, 8, 15, 22 every 28 days. Level 0 (starting dose) Carfilzomib = 20 mg/m2 IV once daily on days 1 of cycle 1 only followed by 36 mg/m2 days 8, 15 in cycle 1, then for all subsequent doses 36 mg/m2 IV once daily on days 1, 8, 15 followed by 13-day rest period (day 16 through 28).
Pomalidomide = 4 mg daily on days 1 - 21 every 28 days. Dexamethasone = 20 mg on days 1, 8, 15, 22 every 28 days. Level +1 Carfilzomib = 20 mg/m2 IV once daily on days 1 of cycle 1 only followed by 45 mg/ m2 days 8, 15 in cycle 1, then for all subsequent doses 45 mg/m2 IV once daily on days 1, 8, 15 followed by 13-day rest period (day 16 through 28).
Pomalidomide = 4 mg daily on days 1 - 21 every 28 days. Dexamethasone = 20 mg on days 1, 8, 15, 22 every 28 days. Level +2 Carfilzomib = 20 mg/m2 IV once daily on days 1 of cycle 1 only followed by 56 mg/m2 days 8, 15 in cycle 1, then for all subsequent doses 56 mg/m2 IV once daily on days 1, 8, 15 followed by 13-day rest period (day 16 through 28).
Pomalidomide = 4 mg daily on days 1 - 21 every 28 days. Dexamethasone = 20 mg on days 1, 8, 15, 22 every 28 days. Patients will be observed during the first cycle of therapy for the assessment of side effects and observation of DLTs.
Dose escalation will proceed as follows:
3 patients will be entered at dose level 0. If none of the 3 experience DLT, dose escalation will continue. If one of three patients experience DLT, three additional patients will be added to this cohort (max 6).
If two of three patients experience a DLT at any given dose, the MTD will have been exceeded and the MTD will be the preceding dose at which < one of 6 patients experienced a DLT.
If no further patients experience DLT (1 of 6) dose escalation will continue. If 2 patients experience DLT (2 of 6) the MTD will have been exceeded and the MTD will be the previous dose at which <1 patient of 6 experienced DLT.
The phase I of the study will end once the MTD has been defined.
PHASE II The phase II of the study will start after the MTD has been defined in the phase I of the study. The dose used to treat patients in the phase II will be the MTD defined in the phase I of the study.
In the second part of the study, the MTD of the association CPd (or in absence of any MTD observed) the doses of dose level 3 (maximum per protocol dose) will be administered to a total of 45 consecutive patients in order to assess response rate and clinical efficacy.
THE PHASE 2 OF THE STUDY WILL START ONLY AFTER THE ANALYSIS OF THE PHASE 1 RESULTS AND THE RELEVANT STUDY REPORT.
MANTEINANCE PERIOD
At the end of 8 courses, maintenance phase will start. Patients will receive:
Carfilzomib = at the MTD achieved in the phase I of the study on days 1, 8, 15 in 28-days cycles.
Pomalidomide = 4 mg daily on days 1 - 21 every 28 days. Dexamethasone = 20 mg on days 1, 8, 15, 22. Patients will be stopped at PD or intolerance. For the maintenance period a continuous assessment of the toxicity and tolerability profile of the CPd combination could permit to the Investigators to continue the treatment using Pomalidomide or Carfilzomib alone according to the dose modification plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Carfilzomib, Drug: Pomalidomide, Drug: DexamethasoneTreatment schedule for 8 cycles of induction: Carfilzomib = 20 mg/m2 IV once daily on days 1 of cycle 1 only followed by 27/36/45/56 mg/m2 days 8, 15 in cycle 1, then for all subsequent doses 27/36/45/56 mg/m2 IV once daily on days 1, 8, 15 followed by 13-day rest period (day 16 through 28). Pomalidomide = 4 mg daily on days 1 - 21 every 28 days. Dexamethasone = 20 mg on days 1, 8, 15, 22 every 28 days. Treatment schedule for maintenance until progression or intolerance: Carfilzomib = at the MTD achieved in the phase I of the study on days 1, 8, 15 in 28-days cycles. Pomalidomide = 4 mg daily on days 1 - 21 every 28 days. Dexamethasone = 20 mg on days 1, 8, 15, 22. |
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. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) for the duration of the study.
- Patients who are primary refractory or relapsed/refractory to Lenalidomide. Subjects must have been received at least 2 consecutive cycles of a prior treatment that include Lenalidomide alone or in combination.
Key exclusion criteria (10 listed)
- Newly diagnosed myeloma patients. Patient with non-secretory MM, unless serum free light chains are present and the ratio is abnormal.
- Pregnant or lactating females. Major surgery within 21 days prior to enrollment. Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to enrolment.
- Patient has active infectious hepatitis type A, B or C or HIV. Unstable angina or myocardial infarction within 4 months prior to enrollment, NYHA Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker.
- Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment.
- Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to enrollment.
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 |
|---|---|---|
| Carfilzomib | Drug | 1 |
| Pomalidomide | Drug | 1 |
| Dexamethasone | Drug | 1 |
Primary outcome
DLT
Time frame: 1 year
The dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of carfilzomib, pomalidomide and dexamethasone (CPd) association.
Partial response
Time frame: 3 years
Determine the rate of partial response (PR) with the CPd association: a PR rate of 25% (p0) is considered not promising (H0) and a 45% (p1) as interesting.
8 secondary outcomes
Toxicities
Time frame: 3 years
PFS
Time frame: 3 years
TTP
Time frame: 3 years
DFS
Time frame: 3 years
DOR
Time frame: 3 years
TTNT
Time frame: 3 years
OS
Time frame: 3 years
Tumor response and survival
Time frame: 3 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 3 Jul 2023.
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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.
Sara Bringhen, MD principal investigator
A.O.U. Città della Salute e della Scienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Carfilzomib, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by European Myeloma Network B.V. at 1 site in Italy.
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 10 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 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
DLT (time frame: 1 year). The study lists 2 primary outcomes in all. 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 3 Jul 2023.