Multiple MyelomaPhase 1NCT04280328
Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma
A Phase 1 study testing Ciforadenant and daratumumab in people with Multiple Myeloma, run by Corvus Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is a Phase 1b open-label study of ciforadenant, an oral, small molecule inhibitor targeting adenosine-2A receptors (A2AR), on safety/tolerability and efficacy in combination with daratumumab, a monoclonal antibody targeting CD38, in relapsed or refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Ciforadenant and daratumumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2020to 1 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed or refractory myeloma.
- 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.
Who cannot join
- POEMS syndrome; non-secretory myeloma (no measurable protein on sFLC assay); amyloidosis.
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
About this study
Official title: An Open-Label Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma
This is a Phase 1b open-label study of ciforadenant, an oral, small molecule inhibitor targeting adenosine-2A receptors (A2AR), on safety/tolerability and efficacy in combination with daratumumab, a monoclonal antibody targeting CD38, in relapsed or refractory multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- Ciforadenant, daratumumab
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiforadenantDrug
Also called CPI-444
100 mg orally twice daily for 28-day cycles
daratumumabDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Ciforadenant in combination with daratumumab | Experimental | Ciforadenant 100 mg orally twice daily in combination with daratumumab IV 16 mg/kg. Receives: Drug: Ciforadenant; Drug: daratumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of ciforadenant in combination with daratumumab relapsed / refractory multiple myeloma.
Incidence of treatment-emergent adverse events, as assessed by NCI CTCAE v.5
Measured: From start of treatment to end of treatment, up to 24 months
Safety and tolerability of ciforadenant in combination with daratumumab relapsed / refractory multiple myeloma.
Incidence of dose-limiting toxicities (DLTs) of CPI-444 in combination with daratumumab
Measured: 28 days following first administration of ciforadnenat in combination with daratumumab
Secondary outcomes (6)
Overall response rate.
According to international myeloma working group guidelines (including stringent complete response [sCR], complete response [CR], very good partial response [VGPR], partial response [PR]).
Measured: From start of treatment to end of treatment, up to 24 months
Duration of response.
Time from the first assessment showing objective response to the date of documented disease progression.
Measured: From start of treatment to end of treatment, up to 24 months
Disease control rate.
Proportion of participants achieving disease control for ≥ 3 months.
Measured: From start of treatment to end of treatment, up to 24 months
Time to next therapy.
Time from end of treatment to starting next anti-myeloma therapy.
Measured: Up to 2 years after end of treatment.
Progression free survival.
Proportion of participants remaining progression free or surviving at a given time.
Measured: Up to 2 years after end of treatment.
Minimal Residual Disease.
Rate of molecular minimal residual disease (MRD) negativity.
Measured: From start of treatment to end of treatment, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start20 Feb 2020
- Primary completion21 Sep 2021
- Study completion1 Mar 2022
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corvus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deborah Strahs, Study director, Corvus Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280328
- Sponsor's protocol ID
- CPI-444-003
- Status last verified
- Mar 2022
- First submitted
- 19 Feb 2020
- Last updated
- 11 Mar 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04280328
- Acronym / sponsor ID
- CPI-444-003
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Corvus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 21 Feb 2020 (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 Phase 1b open-label study of ciforadenant, an oral, small molecule inhibitor targeting adenosine-2A receptors (A2AR), on safety/tolerability and efficacy in combination with daratumumab, a monoclonal antibody targeting CD38, in relapsed or refractory multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ciforadenant in combination with daratumumab | Experimental | Drug: Ciforadenant, Drug: daratumumabCiforadenant 100 mg orally twice daily in combination with daratumumab IV 16 mg/kg. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Relapsed or refractory myeloma.
- 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.
Key exclusion criteria (9 listed)
- POEMS syndrome; non-secretory myeloma (no measurable protein on sFLC assay); amyloidosis.
- 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.
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 |
|---|---|---|
| CiforadenantAlso: CPI-444100 mg orally twice daily for 28-day cycles | Drug | Ciforadenant in combination with daratumumab |
| daratumumab16 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 | Drug | Ciforadenant in combination with daratumumab |
Primary outcome
Safety and tolerability of ciforadenant in combination with daratumumab relapsed / refractory multiple myeloma.
Time frame: From start of treatment to end of treatment, up to 24 months
Incidence of treatment-emergent adverse events, as assessed by NCI CTCAE v.5
Safety and tolerability of ciforadenant in combination with daratumumab relapsed / refractory multiple myeloma.
Time frame: 28 days following first administration of ciforadnenat in combination with daratumumab
Incidence of dose-limiting toxicities (DLTs) of CPI-444 in combination with daratumumab
6 secondary outcomes
Overall response rate.
Time frame: From start of treatment to end of treatment, up to 24 months
Duration of response.
Time frame: From start of treatment to end of treatment, up to 24 months
Disease control rate.
Time frame: From start of treatment to end of treatment, up to 24 months
Time to next therapy.
Time frame: Up to 2 years after end of treatment.
Progression free survival.
Time frame: Up to 2 years after end of treatment.
Minimal Residual Disease.
Time frame: From start of treatment to end of treatment, up to 24 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 Mar 2022.
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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.
Deborah Strahs study director
Corvus Pharmaceuticals
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 Ciforadenant and daratumumab in people with Multiple Myeloma, run by Corvus Pharmaceuticals, Inc. 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 7 inclusion and 9 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 Mar 2022. 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?
Safety and tolerability of ciforadenant in combination with daratumumab relapsed / refractory multiple myeloma. (time frame: From start of treatment to end of treatment, up to 24 months). 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 11 Mar 2022.