Multiple MyelomaPhase 1NCT02655458
Elotuzumab in Autologous Stem Cell Transplantation (ASCT) and Lenalidomide Maintenance for Multiple Myeloma
A Phase 1 study testing Elotuzumab, Lenalidomide and autologous PBMC reconstitution in people with Multiple Myeloma, run by Hearn Jay Cho at 1 site in United States.
Trial summary
The purpose of this study is to explore the combination of Elotuzumab in combination with autologous stem cell transplantation and lenalidomide maintenance to see what side effects it may have and how well it works for the treatment of symptomatic multiple myeloma diagnosed and treated with induction therapy in the… 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?
- Elotuzumab, Lenalidomide and autologous PBMC reconstitution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 13 Jul 2017
- Phase
- Phase 1
- 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
- Subject is, in the investigator's opinion, willing and able to comply with the protocol requirements.
- Subject 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.
- Target Population
- Subjects with symptomatic MM by IMWG criteria who are receiving or have completed induction chemotherapy, who have achieved at least a PR on most recent therapy by IMWG criteria, and are eligible for auto-SCT for consolidation. A specific induction regimen is not dictated for this protocol, however, the induction regimen must not have contained melphalan (L-PAM, Alkeran).
- Age > 18 years or legal age of consent per local regulations.
- Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.
Show all 13Show fewer
- Documented evidence of newly diagnosed, symptomatic MM, by IMWG criteria within one year of enrollment
- Prior lenalidomide exposure is permitted only if the subject did not discontinue lenalidomide due to a related, grade ≥ 3 AE. Age and Reproductive Status
- Men and women of childbearing potential (WOCBP) must be using 2 reliable methods of contraception to avoid pregnancy throughout the study for a period of at least 30 days before and 90 days after the last dose of investigational product in such a manner that the risk of pregnancy is minimized. See Section 4.3.3 for the definition of WOCBP and also refer to the Revlimid Risk Management Plan guidelines.
- WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG). The first should be performed within 10 to 14 days and the second within 24 hours prior to the start of the study drug. A prescription for lenalidomide for a female of childbearing potential must not be issued by the prescriber until negative pregnancy tests have been verified by the prescriber.
- Women must not be breastfeeding.
- Men must agree to use a latex condom and a second form of birth control during sexual contact with WOCBP, even if they have had a successful vasectomy, and must agree not to donate sperm during study drug therapy and for 90 days after therapy.
- Subjects must be willing to refrain from blood donations during study drug therapy and for 8 weeks after therapy.
Who cannot join
- Target Disease
- MGUS, Waldenström's macroglobulinemia, or asymptomatic (smoldering) myeloma.
- Active plasma cell leukemia (defined as either 20% of peripheral white blood cells comprised of plasma/CD138+ cells or an absolute plasma cell count of 2 x 109/L).
- Medical History and Concurrent Diseases
- All AEs of any prior chemotherapy, surgery, or radiotherapy not resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v.4.0) Grade ≤ 2.
- POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
Show all 45Show fewer
- Acute renal failure due solely to readily reversible causes such as hypercalcemia, hyperuricemia, dehydration, hyperviscosity, or acute tubular necrosis from nephrotoxic drugs.
- Significant cardiac disease as determined by the investigator including:
- Known or suspected cardiac amyloidosis
- Congestive heart failure of Class III or IV of the NYHA classification
- Uncontrolled angina, hypertension or arrhythmia
- Myocardial infarction in the past 6 months
- Any uncontrolled or severe cardiovascular disease
- Prior cerebrovascular event with persistent neurologic deficit.
- Known HIV Infection or active hepatitis A, B or C.
- Any medical conditions that, in the investigator's opinion, would impose excessive risk to the subject.
- Examples of such conditions include:
- Any uncontrolled disease, such as pulmonary disease, infection, seizure disorder b. Any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent c. Active infection that requires parenteral anti-microbial or anti-parasitic treatment
- Prior or concurrent malignancy, except for the following:
- Adequately treated basal cell or squamous cell skin cancer;
- Or any other cancer from which the subject has been disease-free for > 5 years
- Uncontrolled diabetes (defined as Hgb A1C > 8.0%)
- Unable to tolerate thromboembolic prophylaxis including, as clinically indicated, aspirin, Coumadin (warfarin) or dose adjusted low-molecular weight heparin. Physical and Laboratory Test Findings
- Corrected serum calcium > 11.5 mg/dl within 2 weeks of enrollment.
- Absolute neutrophil count < 1000 cells/mm3. No granulocyte colony stimulating factors (G-CSF or GMCSF) allowed within 1 week of enrollment. No pegylated granulocyte colony stimulating factors are allowed within 3 weeks of treatment start.
- Platelets < 75,000 cell/mm3 (75 x 109/L). Qualifying laboratory value must occur at most recent measurement before enrollment and must be no more than 14 days before enrollment. No transfusions are allowed within 72 hours before qualifying laboratory value.
- Hemoglobin < 8 g/dL. Qualifying laboratory value must occur at most recent measurement before enrollment and must be no more than 14 days before enrollment. No transfusions are allowed within 72 hours before qualifying laboratory value.
- Total bilirubin > 2X ULN ,or direct bilirubin > 2.0 mg/dL.(except patients with Gilbert's syndrome then total bilirubin >2X ULN allowed in the absence of other hepatic signs or symptoms)
- AST or ALT > 3X ULN.
- CrCl < 60 ml/min by Cockcroft-Gault Formula Prior Therapy or Surgery
- Major surgery within 3 weeks prior to treatment.
- Kyphoplasty or vertebroplasty within 1 week of enrollment.
- Prior allogeneic stem cell transplant
- Treatment with plasmapheresis within 4 weeks before enrollment.
- Prior therapy with elotuzumab or any IMiD (including pomalidomide), except for prior thalidomide or lenalidomide (as defined in inclusion criteria).
- NSAIDs, IV contrast, aminoglycosides, or other potentially nephrotoxic drugs within 2 weeks of enrollment.
- Steroids within 3 weeks of enrollment, except:
- ≤ 10 mg prednisone or equivalent per day
- Steroid with little to no systemic absorption (ie, topical or inhaled steroids) Allergies and Adverse Drug Reaction
- Known hypersensitivity to lenalidomide, dexamethasone, any excipients in the elotuzumab formulation (sodium citrate, citric acid, sucrose and polysorbate 80) or recombinant protein.
- History of Grade 4 rash associated with thalidomide treatment. Sex and Reproductive Status
- Women of childbearing potential (WOCBP) who are pregnant or lactating or unwilling to use 2 forms of effective birth control.
- Men who are fertile and sexually active unwilling to use 2 forms of effective birth control if their partners are WOCBP. Other Exclusion Criteria
- Prisoners or subjects who are involuntarily incarcerated.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Phase 1 Study of Elotuzumab in Combination With Autologous Stem Cell Transplantation and Lenalidomide Maintenance for Multiple Myeloma
The purpose of this study is to explore the combination of Elotuzumab in combination with autologous stem cell transplantation and lenalidomide maintenance to see what side effects it may have and how well it works for the treatment of symptomatic multiple myeloma diagnosed and treated with induction therapy in the past year.
Induction therapy is the first phase of treatment for multiple myeloma. The goal of induction therapy for multiple myeloma is to reduce the number of plasma cells in the bone marrow and the proteins that the plasma cells produce. Induction therapy is usually given for 3-4 weeks.
Read more
An autologous peripheral blood stem cell transplant is a procedure in which immature "stem cells" are collected and stored for future use. A high dose of chemotherapy is given to the patient to destroy myeloma cells, and the patient's stem cells are replaced.
The investigational drug in this program is elotuzumab. Elotuzumab is known as BMS-901608. Elotuzumab is a manufactured protein directed against a target found on multiple myeloma cells. Lenalidomide is currently approved for patients with multiple myeloma. Melphalan and cyclophosphamide, the drugs used during stem cell collection and transplant, are also approved by the U.S. FDA. Melphalan is an FDA-approved chemotherapy for multiple myeloma and is used as high-dose treatment prior to stem cell transplantation. Cyclophosphamide is an FDA-approved chemotherapy that may be used, either alone, or in combination with other drugs to treat multiple myeloma.
Read the detailed description
This is a Phase 1b, open-label, trial investigating elotuzumab and autologous PBMC reconstitution with auto-SCT consolidation therapy and lenalidomide maintenance. Fifteen patients will be enrolled in this study.
This study is based on the hypothesis that the addition of Elotuzumab and autologous PBMC reconstitution to standard-of-care auto-SCT and lenalidomide maintenance will be safe and feasible. Furthermore, we hypothesize that Elotuzumab and PBMC reconstitution will target residual myeloma cells, enhance NK cell activation and ADCC, and promote tumor-specific humoral and cellular immune responses against myeloma cells, resulting in long-term maintenance of the minimal residual disease state.
- Conditions
- Multiple Myeloma
- Being tested
- Elotuzumab, Lenalidomide, autologous PBMC reconstitution, ASCT
- Keywords
- Multiple Myeloma, Induction Therapy, Autologous Stem Cell Transplant, ASCT, Auto-SCT
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElotuzumabDrug
Also called Empliciti
The following must also be administered before any elotuzumab:
Dexamethasone 8 mg IV (on the day of elotuzumab infusion 45-90 mins prior to the start of infusion), the following 30 - 90 minutes prior to start of infusion: H1 blocker: diphenhydramine (25 - 50 mg po or IV) or equivalent, H2 blocker: ranitidine (50 mg IV) or equivalent (adjusted for renal failure as indicated), acetaminophen (650 - 1000 mg po).
LenalidomideDrug
Also called Revlimid
On the days of elotuzumab administration, the dose of lenalidomide is to be administered at least 2 hours after completion of elotuzumab dosing. Aspirin 81 mg PO daily will also be prescribed for DVT prophylaxis.
autologous PBMC reconstitutionOther
Autologous peripheral blood mononuclear cell collection and reconstitution. PBMC will be collected from patients by standard apheresis procedures. Up to 25 ml of autologous plasma will also be recovered for dilution of cryopreserved products (if necessary). For reconstitution, Patients will be pre-medicated as per each institution's standard protocols prior to reinfusion of PBMC products. Patient ID will be checked and verified by nursing staff and the products will be re-infused by continuous intravenous infusion pump. Patient vital signs will be monitored every 15 minutes for the duration of the procedure as per standard reinfusion protocol.
ASCTOther
Also called auto-SCT consolidation therapy
Autologous peripheral blood stem cell transplantation. (stem cells from the patient's own marrow are "harvested," stored and then returned to the body (engrafted). To be done as part of standard of care.
| Study group | Role | What they receive |
|---|---|---|
| autologous PBMC reconstitution, Elotuzumab, Lenalidomide | Experimental | Max number of cycles is 12. Elotuzumab will be administered IV 20 mg/kg on Day 1 of each cycle. Lenalidomide dosing will start with cycle 4 at 10 mg orally daily days 1-21. Receives: Drug: Elotuzumab; Drug: Lenalidomide; Other: autologous PBMC reconstitution; Other: ASCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of completion of treatment
Safety and tolerability will be measured by the number of evaluable patients who complete the treatment protocol.
Measured: up to 24 months
Secondary outcomes (6)
IFE level
Immunofixation Serum Test (IFE) level
Measured: up to 24 months
sFLC level
Serum Free Light Chain analysis (sFLC) level
Measured: up to 24 months
Bone marrow MRD analysis
Bone marrow disease (MRD) is the name for small numbers of leukaemic cells in the bone marrow
Measured: up to 24 months
Progression-Free Survival
number of participants at 24 months who are progression-free
Measured: up to 24 months
CyTOF mass cytometry
Immune cell reconstitution will be assessed by Cytometry by Time-Of-Flight (CyTOF) mass cytometry. This method quantifies and characterizes all cellular immune compartments.
Measured: up to 24 months
SPEP level
Serum protein electrophoresis (SPEP) level
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startJan 2016
- Primary completion13 Jul 2017
- Study completion13 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hearn Jay Cho
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Hearn Jay Cho, Icahn School of Medicine at Mount Sinai
- Investigators
- Hearn Jay Cho, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655458
- Sponsor's protocol ID
- GCO 15-1275
- Status last verified
- Aug 2017
- First submitted
- 12 Jan 2016
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Coffey DG, Osman K, Aleman A, Bekri S, Kats S, Dhadwal A, Catamero D, Kim-Schulze S, Gnjatic S, Chari A, Parekh S, Jagannath S, Cho HJ. Phase 1 study combining elotuzumab with autologous stem cell transplant and lenalidomide for multiple myeloma. J Immunother Cancer. 2024 Apr 12;12(4):e008110. doi: 10.1136/jitc-2023-008110.
PubMed 38609316
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Elotuzumab in Combination With Autologous Stem Cell Transplantation and Lenalidomide Maintenance for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02655458
- Acronym / sponsor ID
- GCO 15-1275
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Induction Therapy, Autologous Stem Cell Transplant, ASCT, Auto-SCT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hearn Jay ChoUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jan 2016
- Primary completion
- 13 Jul 2017 (actual)
- Study completion
- 13 Jul 2017 (actual)
- First posted
- 14 Jan 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.
The purpose of this study is to explore the combination of Elotuzumab in combination with autologous stem cell transplantation and lenalidomide maintenance to see what side effects it may have and how well it works for the treatment of symptomatic multiple myeloma diagnosed and treated with induction therapy in the past year.
Induction therapy is the first phase of treatment for multiple myeloma. The goal of induction therapy for multiple myeloma is to reduce the number of plasma cells in the bone marrow and the proteins that the plasma cells produce. Induction therapy is usually given for 3-4 weeks.
An autologous peripheral blood stem cell transplant is a procedure in which immature "stem cells" are collected and stored for future use. A high dose of chemotherapy is given to the patient to destroy myeloma cells, and the patient's stem cells are replaced.
The investigational drug in this program is elotuzumab. Elotuzumab is known as BMS-901608. Elotuzumab is a manufactured protein directed against a target found on multiple myeloma cells. Lenalidomide is currently approved for patients with multiple myeloma. Melphalan and cyclophosphamide, the drugs used during stem cell collection and transplant, are also approved by the U.S. FDA. Melphalan is an FDA-approved chemotherapy for multiple myeloma and is used as high-dose treatment prior to stem cell transplantation. Cyclophosphamide is an FDA-approved chemotherapy that may be used, either alone, or in combination with other drugs to treat multiple myeloma.
Detailed description
This is a Phase 1b, open-label, trial investigating elotuzumab and autologous PBMC reconstitution with auto-SCT consolidation therapy and lenalidomide maintenance. Fifteen patients will be enrolled in this study.
This study is based on the hypothesis that the addition of Elotuzumab and autologous PBMC reconstitution to standard-of-care auto-SCT and lenalidomide maintenance will be safe and feasible. Furthermore, we hypothesize that Elotuzumab and PBMC reconstitution will target residual myeloma cells, enhance NK cell activation and ADCC, and promote tumor-specific humoral and cellular immune responses against myeloma cells, resulting in long-term maintenance of the minimal residual disease state.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autologous PBMC reconstitution, Elotuzumab, Lenalidomide | Experimental | Drug: Elotuzumab, Drug: Lenalidomide, Other: autologous PBMC reconstitution, Other: ASCTMax number of cycles is 12. Elotuzumab will be administered IV 20 mg/kg on Day 1 of each cycle. Lenalidomide dosing will start with cycle 4 at 10 mg orally daily days 1-21. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject is, in the investigator's opinion, willing and able to comply with the protocol requirements.
- Subject 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 subject at any time without prejudice to their future medical care.
- Target Population
- Subjects with symptomatic MM by IMWG criteria who are receiving or have completed induction chemotherapy, who have achieved at least a PR on most recent therapy by IMWG criteria, and are eligible for auto-SCT for consolidation. A specific induction regimen is not dictated for this protocol, however, the induction regimen must not have contained melphalan (L-PAM, Alkeran).
- Age > 18 years or legal age of consent per local regulations.
Key exclusion criteria (45 listed)
- Target Disease
- MGUS, Waldenström's macroglobulinemia, or asymptomatic (smoldering) myeloma.
- Active plasma cell leukemia (defined as either 20% of peripheral white blood cells comprised of plasma/CD138+ cells or an absolute plasma cell count of 2 x 109/L).
- Medical History and Concurrent Diseases
- All AEs of any prior chemotherapy, surgery, or radiotherapy not resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v.4.0) Grade ≤ 2.
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 |
|---|---|---|
| ElotuzumabAlso: EmplicitiThe following must also be administered before any elotuzumab: Dexamethasone 8 mg IV (on the day of elotuzumab infusion 45-90 mins prior to the start of infusion), the following 30 - 90 minutes prior to start of infusion: H1 blocker: diphenhydramine (25 - 50 mg po or IV) or equivalent, H2 blocker: ranitidine (50 mg IV) or equivalent (adjusted for renal failure as indicated), acetaminophen (650 - 1000 mg po). | Drug | autologous PBMC reconstitution, Elotuzumab, Lenalidomide |
| LenalidomideAlso: RevlimidOn the days of elotuzumab administration, the dose of lenalidomide is to be administered at least 2 hours after completion of elotuzumab dosing. Aspirin 81 mg PO daily will also be prescribed for DVT prophylaxis. | Drug | autologous PBMC reconstitution, Elotuzumab, Lenalidomide |
| autologous PBMC reconstitutionAutologous peripheral blood mononuclear cell collection and reconstitution. PBMC will be collected from patients by standard apheresis procedures. Up to 25 ml of autologous plasma will also be recovered for dilution of cryopreserved products (if necessary). For reconstitution, Patients will be pre-medicated as per each institution's standard protocols prior to reinfusion of PBMC products. Patient ID will be checked and verified by nursing staff and the products will be re-infused by continuous intravenous infusion pump. Patient vital signs will be monitored every 15 minutes for the duration of the procedure as per standard reinfusion protocol. | Other | autologous PBMC reconstitution, Elotuzumab, Lenalidomide |
| ASCTAlso: auto-SCT consolidation therapyAutologous peripheral blood stem cell transplantation. (stem cells from the patient's own marrow are "harvested," stored and then returned to the body (engrafted). To be done as part of standard of care. | Other | autologous PBMC reconstitution, Elotuzumab, Lenalidomide |
Primary outcome
Incidence of completion of treatment
Time frame: up to 24 months
Safety and tolerability will be measured by the number of evaluable patients who complete the treatment protocol.
6 secondary outcomes
IFE level
Time frame: up to 24 months
sFLC level
Time frame: up to 24 months
Bone marrow MRD analysis
Time frame: up to 24 months
Progression-Free Survival
Time frame: up to 24 months
CyTOF mass cytometry
Time frame: up to 24 months
SPEP level
Time frame: up to 24 hours
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 Aug 2017.
- Derived from this study: PubMed 38609316Coffey DG, Osman K, Aleman A, Bekri S, Kats S, Dhadwal A, Catamero D, Kim-Schulze S, Gnjatic S, Chari A, Parekh S, Jagannath S, Cho HJ. Phase 1 study combining elotuzumab with autologous stem cell transplant and lenalidomide for multiple myeloma. J Immunother Cancer. 2024 Apr 12;12(4):e008110. doi: 10.1136/jitc-2023-008110.
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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.
Hearn Jay Cho, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Elotuzumab, Lenalidomide and autologous PBMC reconstitution in people with Multiple Myeloma, run by Hearn Jay Cho at 1 site 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 13 inclusion and 45 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 Aug 2017. 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 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 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.
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?
Incidence of completion of treatment (time frame: up to 24 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 NCT02655458, which also lists 1 linked publication.
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 Aug 2017.