Leukemia, MyeloidPhase 1NCT04748848
A Safety, Tolerability and Preliminary Efficacy Study of CC-90011 in Combination With Venetoclax and Azacitidine in R/R Acute Myeloid Leukemia and Treatment-naïve Participants Not Eligible for Intensive Therapy
A Phase 1 study testing CC-90011, Venetoclax and Azacitidine in people with Leukemia, Myeloid, run by Celgene at 17 sites in 4 countries.
Trial summary
CC-90011-AML-002 is a Phase 1/2, open-label, multicenter study to assess the safety, tolerability, and preliminary efficacy of CC-90011 given concurrently with Venetoclax and Azacitidine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid
- What is being tested?
- CC-90011, Venetoclax and Azacitidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 17 sitesin 4 countries
- Study dates
- 14 Oct 2021to 9 Mar 2022
- 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
- Participants must satisfy the following criteria to be enrolled in the study:
- All participants (Parts I, II, and III):
- 1. Participant must understand and voluntarily sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures being conducted.
- 3. Participant must have a projected life expectancy of at least 12 weeks. 4. Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- 5. Participants must have the required protocol baseline laboratory values 6. Participant has adequate organ function 7. Participant must be able and willing to undergo hospitalization, hydration, and treatment with a uric acid-reducing agent prior to the first dose of venetoclax and during Cycle 1.
- Part I only:
Show all 11Show fewer
- 8. Relapsed and/or refractory acute myeloid leukemia (AML) as defined by the World Health Organization (WHO) Classification and is ≥ 18 years of age at the time of signing the ICF who are not eligible to receive further intensive therapy and:
- Has failed to have a complete remission (CR) or CR with incomplete hematologic recovery (Cri) after induction plus reinduction with intensive chemotherapy (anthracycline plus cytarabine containing regimens) or 2 cycles of low intensity therapy (either 2 cycles of the same regimen or 1 cycle of 2 different regimens) OR
- Has relapsed from CR from either intensive or low-intensity therapy. Participants with second relapse are also eligible
- Part II and Part III only:
- 9. Histologically confirmed treatment naïve Acute myeloid leukemia (AML) as defined by the 2008 World Health Organization (WHO) Classification, including secondary AML and therapy related AML, and is ≥ 75 years of age at the time of signing the ICF, or is ≥ 18 to 74 years at the time of signing the ICF with comorbidities precluding the use of intensive induction chemotherapy 10. Participant has not received prior therapy for AML with the exception of hydroxyurea to treat hyperleukocytosis.
Who cannot join
- The presence of any of the following will exclude a participant from enrollment:
- All participants (Parts I, II, and III):
- Participant is suspected or proven to have acute promyelocytic leukemia (APL) based on morphology, immunophenotype, molecular assay, or karyotype.
- Participant has favorable risk cytogenetics
- Participants with AML who may receive fms-like tyrosine kinase 3 (FLT3) inhibitor directed therapy.
- Participant has or is suspected of having active central nervous system (CNS) involvement.
Show all 33Show fewer
- Participant has an active, uncontrolled infection except participants with infection under active treatment and controlled with antibiotics, antifungals, or antivirals are eligible.
- Participant with prior autologous hematopoietic stem cell transplant (HSCT) who, in the investigator's judgment, have not fully recovered from the effects of the last transplant (eg, transplant related side effects).
- Participant had prior allogeneic HSCT with either standard or reduced intensity conditioning ≤ 6 months prior to dosing.
- Participants on systemic immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD). The use of topical steroids for ongoing skin or ocular GVHD is permitted.
- Participant has immediate life-threatening, severe complications of leukemia such as disseminated/uncontrolled infection, uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation. The participant should be afebrile for at least 72 hours.
- Participants requiring treatment with strong or moderate CYP3A inhibitors/inducers.
- Participant has ongoing treatment with chronic, therapeutic dosing of anticoagulants.
- Participant has a history of concurrent secondary cancers requiring active, ongoing systemic treatment.
- Participant has known human immunodeficiency virus (HIV) infection.
- Participant has known chronic active hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Participant who is seropositive due to HBV vaccination is eligible.
- Participant who has no active viral infection and is under adequate prophylaxis against HBV reactivation is eligible.
- Participant is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.
- Participant has impaired cardiac function or clinically significant cardiac diseases
- Participant has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or Star fruit within 3 days prior to first venetoclax dose through last dose of venetoclax.
- Pregnant women are excluded from this study due to potential teratogenic and/or abortifacient effect of this therapy. Nursing mothers should stop breastfeeding in order to be eligible due to potential risk for Adverse Events (AEs) in a nursing infant.
- Participant has had previous treatment with a lysine-specific demethylase 1A (LSD1) inhibitor.
- Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
- Participant has any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study.
- Participant has any condition that confounds the ability to interpret data from the study.
- Participant received live COVID-19 vaccines within 30 days prior to initiation of study treatment
- Participants currently in other interventional trials, including those for COVID-19, may not participate in BMS clinical trials until the protocol specific washout period is achieved. If a study participant has received an investigational COVID-19 vaccine or other investigational product designed to treat or prevent COVID-19 prior to screening, enrollment must be delayed until the biologic impact of the vaccine or investigational product is stabilized, as determined by discussion between the Investigator and the Medical Monitor.
- Part I only:
- Participant had prior treatment with venetoclax for AML, either as monotherapy or in combination with other agents.
- Part II and Part III only:
- Participant had prior treatment with hypomethylating agent (HMA) or chemotherapy for antecedent hematologic disorders. Prior treatment with hydroxyurea is permitted.
- Participant has received systemic anticancer therapy (including investigational therapy), radiotherapy, or immunotherapy < 14 days or 5 half-lives, whichever is shorter, prior to the first dose of CC-90011.
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
United States11 sites
Local Institution - 111
Chicago, Illinois, 60611
Local Institution - 116
Cleveland, Ohio, 44195
Local Institution - 115
Columbus, Ohio, 43210
Local Institution - 104
Dallas, Texas, 75246
Local Institution - 110
Duarte, California, 91010-301
Local Institution - 118
Durham, North Carolina, 27710
Local Institution - 101
Houston, Texas, 77030
Local Institution - 108
Miami, Florida, 33136
Local Institution - 103
New Haven, Connecticut, 06510
Local Institution - 121
New York, New York, 10029
Local Institution - 120
Seattle, Washington, 98104
Spain4 sites
Local Institution - 803
Barcelona, 08035
Local Institution - 800
Barcelona, 08907
Local Institution - 802
Madrid, 28007
Local Institution - 801
Seville, 41013
About this study
Official title: A Phase 1/2, Open-label, Multicenter Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of CC-90011 in Combination With Venetoclax and Azacitidine in R/R Acute Myeloid Leukemia (AML) and Treatment-naïve Subjects With AML Who Are Not Eligible for Intensive Induction Chemotherapy
CC-90011-AML-002 is a Phase 1/2, open-label, multicenter study to assess the safety, tolerability, and preliminary efficacy of CC-90011 given concurrently with Venetoclax and Azacitidine. This study will include 3 parts: a dose escalation part in R/R AML, a dose escalation part in ndAML (treatment-naïve participants with AML who are ≥ 75 years of age or are ≥ 18 to 74 years of age and otherwise not eligible for intensive induction chemotherapy), and a randomized dose expansion part in ndAML of Venetoclax and Azacitidine with or without CC-90011.
- Conditions
- Leukemia, Myeloid
- Being tested
- CC-90011, Venetoclax, Azacitidine
- Keywords
- Acute Myeloid Leukemia, CC-90011, Venetoclax, Azacitidine, LSD-1 inhibitor, Minimal residual disease
- Medical subject headings
- Leukemia, Myeloid, Leukemia, Myeloid, Acute, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-90011Drug
CC-90011 will be given PO on Days 1, 8, and 15 of continuous 4-week (28-day) cycle. The dose escalation is designed to explore three dose levels of CC-90011, for example 20, 40, and 60 mg as determined by Bayesian design.
VenetoclaxDrug
Venetoclax is administered orally QD on Days 1 to 28 of each 28-day cycle with a brief dose ramp-up for Cycle 1 with the dosing of 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Day 3. Venetoclax should be administered at 400 mg on subsequent days.
AzacitidineDrug
Azacitidine is administered on Days 1 to 7 of each 28-day cycle as an IV infusion or SC injection at 75 mg/m2
VenetoclaxDrug
Venetoclax is administered orally QD on Days 1 to 28 of each 28-day cycle
CC-90011Drug
CC-90011 will be given PO on Days 1, 8, and 15 of continuous 4-week (28-day) cycle at the recommended phase to dose of CC-90011 confirmed in dose escalation.
| Study group | Role | What they receive |
|---|---|---|
| CC-90011 in combination with Venetoclax and Azacitidine in Dose Escalation | Experimental | CC-90011 in combination with venetoclax and azacitidine in dose escalation Receives: Drug: CC-90011; Drug: Venetoclax; Drug: Azacitidine |
| Venetoclax and Azacitidine | Experimental | Venetoclax and Azacitidine control arm in dose expansion. The participants will be randomized to the treatment arm or control arm at a 2:1 ratio. Receives: Drug: Azacitidine; Drug: Venetoclax |
| CC-90011 in combination with Venetoclax and Azacitidine in Dose Expansion | Experimental | CC-90011 in combination with venetoclax and azacitidine in dose expansion Receives: Drug: Venetoclax; Drug: Azacitidine; Drug: CC-90011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE
Measured: From ICF signature until 28 days after last dose of CC- 90011 and all combination agents
Recommended Phase 2 dose (RP2D)
The RP2D will include evaluation of DLTs and MTD using NCI CTCAE criteria
Measured: Up to approximately Cycle 1 (each cycle is 28 days)
Secondary outcomes (12)
Complete remission (CR) Rate
Defined as the rate of achieving CR (as assessed by the Investigator and by programmatic outputs by the Sponsor)
Measured: Up to approximately 10 months
Complete remission with partial hematologic recovery (CRh) Rate
Defined as the rate of achieving CRh (as assessed by the Investigator and by programmatic outputs by the Sponsor)
Measured: Up to approximately 2 years
Overall response rate (ORR)
Defined as the rate of achieving CR/CRMRD-/CRi/PR/MLFS
Measured: Up to approximately 2 years
Duration of response (CR)
Time from the first CR to the date of documented disease relapse or death, whichever is earlier.
Measured: Up to approximately 2 years
Duration of response (CR/CRh)
Time from the first CR or CRh to the date of documented disease relapse or death, whichever is earlier.
Measured: Up to approximately 2 years
Duration of response (CR/ CRMRD-/ CRi/ PR/MLFS)
Time from the first CR, CRMRD-, CRi, PR or MLFS to the date of documented disease relapse, progression, or death, whichever is earlier.
Measured: Up to approximately 2 years
Event-free survival (EFs)_Part III Only
Time from study randomization to the date of treatment failure, relapse from CR or death from any cause, whichever comes first.
Measured: Up to approximately 2 years
Overall survival (OS)_Part III Only
Time from study randomization to the date of death due to any cause.
Measured: Up to approximately 2 years
Minimal residual disease (MRD) Response Rate_Part II and III only
The rate of having at least a one log reduction in disease burden or an MRD negative (10-3) test result.
Measured: Up to approximately 2 years
Minimal residual disease (MRD) Conversion Rate_Part II and III Only
The rate of participants achieving MRD negativity (10-3) at any time on therapy.
Measured: Up to approximately 2 years
Complete response with incomplete hematologic recovery (CRi) rate
Defined as the rate of achieving CRi (as assessed by the Investigator and by programmatic outputs by the Sponsor)
Measured: Up to approximately 2 years
Duration of response (CR/CRi)
Time from the first CR or CRi to the date of documented disease relapse or death, whichever is earlier.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start14 Oct 2021
- Primary completion9 Mar 2022
- Study completion9 Mar 2022
Why it stopped: Business objectives have changed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, MyeloidStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748848
- Sponsor's protocol ID
- CC-90011-AML-002
- Other IDs
- U1111-1251-6973, 2020-005341-16
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2021
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-label, Multicenter Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of CC-90011 in Combination With Venetoclax and Azacitidine in R/R Acute Myeloid Leukemia (AML) and Treatment-naïve Subjects With AML Who Are Not Eligible for Intensive Induction Chemotherapy
- ClinicalTrials.gov ID
- NCT04748848
- Acronym / sponsor ID
- CC-90011-AML-002
- Conditions
- Leukemia, Myeloid
- Keywords
- Acute Myeloid Leukemia, CC-90011, Venetoclax, Azacitidine, LSD-1 inhibitor, Minimal residual disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 10 Feb 2021 (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.
CC-90011-AML-002 is a Phase 1/2, open-label, multicenter study to assess the safety, tolerability, and preliminary efficacy of CC-90011 given concurrently with Venetoclax and Azacitidine. This study will include 3 parts: a dose escalation part in R/R AML, a dose escalation part in ndAML (treatment-naïve participants with AML who are ≥ 75 years of age or are ≥ 18 to 74 years of age and otherwise not eligible for intensive induction chemotherapy), and a randomized dose expansion part in ndAML of Venetoclax and Azacitidine with or without CC-90011.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CC-90011 in combination with Venetoclax and Azacitidine in Dose Escalation | Experimental | Drug: CC-90011, Drug: Venetoclax, Drug: AzacitidineCC-90011 in combination with venetoclax and azacitidine in dose escalation |
| Venetoclax and Azacitidine | Experimental | Drug: Azacitidine, Drug: VenetoclaxVenetoclax and Azacitidine control arm in dose expansion. The participants will be randomized to the treatment arm or control arm at a 2:1 ratio. |
| CC-90011 in combination with Venetoclax and Azacitidine in Dose Expansion | Experimental | Drug: Venetoclax, Drug: Azacitidine, Drug: CC-90011CC-90011 in combination with venetoclax and azacitidine in dose expansion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Participant must understand and voluntarily sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures being conducted.
- 3. Participant must have a projected life expectancy of at least 12 weeks. 4. Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- 5. Participants must have the required protocol baseline laboratory values 6. Participant has adequate organ function 7. Participant must be able and willing to undergo hospitalization, hydration, and treatment with a uric acid-reducing agent prior to the first dose of venetoclax and during Cycle 1.
- 8. Relapsed and/or refractory acute myeloid leukemia (AML) as defined by the World Health Organization (WHO) Classification and is ≥ 18 years of age at the time of signing the ICF who are not eligible to receive further intensive therapy and:
- Has failed to have a complete remission (CR) or CR with incomplete hematologic recovery (Cri) after induction plus reinduction with intensive chemotherapy (anthracycline plus cytarabine containing regimens) or 2 cycles of low intensity therapy (either 2 cycles of the same regimen or 1 cycle of 2 different regimens) OR
Key exclusion criteria (33 listed)
- Participant is suspected or proven to have acute promyelocytic leukemia (APL) based on morphology, immunophenotype, molecular assay, or karyotype.
- Participant has favorable risk cytogenetics
- Participants with AML who may receive fms-like tyrosine kinase 3 (FLT3) inhibitor directed therapy.
- Participant has or is suspected of having active central nervous system (CNS) involvement.
- Participant has an active, uncontrolled infection except participants with infection under active treatment and controlled with antibiotics, antifungals, or antivirals are eligible.
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 |
|---|---|---|
| CC-90011CC-90011 will be given PO on Days 1, 8, and 15 of continuous 4-week (28-day) cycle. The dose escalation is designed to explore three dose levels of CC-90011, for example 20, 40, and 60 mg as determined by Bayesian design. | Drug | CC-90011 in combination with Venetoclax and Azacitidine in Dose Escalation |
| VenetoclaxVenetoclax is administered orally QD on Days 1 to 28 of each 28-day cycle with a brief dose ramp-up for Cycle 1 with the dosing of 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Day 3. Venetoclax should be administered at 400 mg on subsequent days. | Drug | CC-90011 in combination with Venetoclax and Azacitidine in Dose Escalation, CC-90011 in combination with Venetoclax and Azacitidine in Dose Expansion |
| AzacitidineAzacitidine is administered on Days 1 to 7 of each 28-day cycle as an IV infusion or SC injection at 75 mg/m2 | Drug | CC-90011 in combination with Venetoclax and Azacitidine in Dose Escalation, CC-90011 in combination with Venetoclax and Azacitidine in Dose Expansion, Venetoclax and Azacitidine |
| VenetoclaxVenetoclax is administered orally QD on Days 1 to 28 of each 28-day cycle | Drug | Venetoclax and Azacitidine |
| CC-90011CC-90011 will be given PO on Days 1, 8, and 15 of continuous 4-week (28-day) cycle at the recommended phase to dose of CC-90011 confirmed in dose escalation. | Drug | CC-90011 in combination with Venetoclax and Azacitidine in Dose Expansion |
Primary outcome
Adverse Events (AEs)
Time frame: From ICF signature until 28 days after last dose of CC- 90011 and all combination agents
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE
Recommended Phase 2 dose (RP2D)
Time frame: Up to approximately Cycle 1 (each cycle is 28 days)
The RP2D will include evaluation of DLTs and MTD using NCI CTCAE criteria
12 secondary outcomes
Complete remission (CR) Rate
Time frame: Up to approximately 10 months
Complete remission with partial hematologic recovery (CRh) Rate
Time frame: Up to approximately 2 years
Overall response rate (ORR)
Time frame: Up to approximately 2 years
Duration of response (CR)
Time frame: Up to approximately 2 years
Duration of response (CR/CRh)
Time frame: Up to approximately 2 years
Duration of response (CR/ CRMRD-/ CRi/ PR/MLFS)
Time frame: Up to approximately 2 years
Event-free survival (EFs)_Part III Only
Time frame: Up to approximately 2 years
Overall survival (OS)_Part III Only
Time frame: Up to approximately 2 years
Minimal residual disease (MRD) Response Rate_Part II and III only
Time frame: Up to approximately 2 years
Minimal residual disease (MRD) Conversion Rate_Part II and III Only
Time frame: Up to approximately 2 years
Complete response with incomplete hematologic recovery (CRi) rate
Time frame: Up to approximately 2 years
Duration of response (CR/CRi)
Time frame: Up to approximately 2 years
Results and safety
The study was stopped early (reason given: Business objectives have changed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CC-90011, Venetoclax and Azacitidine in people with Leukemia, Myeloid, run by Celgene at 17 sites in 4 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 11 inclusion and 33 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: stopped early, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Spain, Belgium, France. 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 was stopped early (reason given: Business objectives have changed.). Results are not available in the source record.
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?
Adverse Events (AEs) (time frame: From ICF signature until 28 days after last dose of CC- 90011 and all combination agents). 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 2 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.