Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma
NCT ID: NCT04280328
Last Updated: 2022-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
7 participants
INTERVENTIONAL
2020-02-20
2022-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate Dara-CyBorD in Previously Untreated and Relapsed Subjects With Multiple Myeloma
NCT02951819
Phase II Study of the CD38 Antibody Daratumumab in Patients With High-Risk MGUS and Low-Risk Smoldering Multiple Myeloma
NCT03236428
Early Access Treatment With Daratumumab for (Relapsed or Refractory) Multiple Myeloma
NCT02477891
Cyclophosphamide-Bortezomib-Dexamethasone (CyBorD) With Daratumumab (DARA)
NCT02955810
An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD
NCT01985126
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ciforadenant in combination with daratumumab
Ciforadenant 100 mg orally twice daily in combination with daratumumab IV 16 mg/kg.
Ciforadenant
100 mg orally twice daily for 28-day cycles
daratumumab
16 mg/kg administered intravenously as follows based on 28-day cycles:
* Cycles 1 - 2: Days 1, 8, 15, and 22
* Cycles 3 - 6: Days 1 and 15
* Cycles 7 - 24: Day 1
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ciforadenant
100 mg orally twice daily for 28-day cycles
daratumumab
16 mg/kg administered intravenously as follows based on 28-day cycles:
* Cycles 1 - 2: Days 1, 8, 15, and 22
* Cycles 3 - 6: Days 1 and 15
* Cycles 7 - 24: Day 1
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must have been exposed to at least 2 cycles of an IMiD containing regimen and PI containing regimen and must be refractory to at least one of the two.
* Must have completed and tolerated 2 cycles of daratumumab or other anti-CD38 targeting antibodies.
* Active myeloma requiring systemic treatment.
* Measurable disease per protocol.
* ECOG performance status of 0 - 2.
* Life expectancy of at least 3 months.
Exclusion Criteria
* History of select prior malignancies.
* Previous intolerance to daratumumab or any study drug.
* Received an allogeneic stem cell transplant within 12 months, or an autologous stem cell transplant within 6 months, or have ongoing toxicity related to transplant.
* Have an active infection or serious comorbid medical condition.
* Any live attenuated vaccination against infectious diseases (e.g., influenza, varicella) within 4 weeks of initiation of study treatment; uncontrolled human immunodeficiency virus, or positive tests for hepatitis B or hepatitis C.
* Female participants pregnant or breast-feeding.
* Screening chemistry and blood counts within protocol limits
* Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressant medication during study treatment.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Corvus Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Deborah Strahs
Role: STUDY_DIRECTOR
Corvus Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CPI-444-003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.