Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

An Open-Label Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04280328
• Other study ID #: CPI-444-003
• Status: Completed
• Phase: Phase 1
• Start date: February 20, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2022
• Source: Corvus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: March 1, 2022
• Est. primary completion date: September 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Corvus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From start of treatment to end of treatment, up to 24 months
Primary	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	28 days following first administration of ciforadnenat in combination with daratumumab
Secondary	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]).	From start of treatment to end of treatment, up to 24 months
Secondary	Duration of response.	Time from the first assessment showing objective response to the date of documented disease progression.	From start of treatment to end of treatment, up to 24 months
Secondary	Disease control rate.	Proportion of participants achieving disease control for = 3 months.	From start of treatment to end of treatment, up to 24 months
Secondary	Time to next therapy.	Time from end of treatment to starting next anti-myeloma therapy.	Up to 2 years after end of treatment.
Secondary	Progression free survival.	Proportion of participants remaining progression free or surviving at a given time.	Up to 2 years after end of treatment.
Secondary	Minimal Residual Disease.	Rate of molecular minimal residual disease (MRD) negativity.	From start of treatment to end of treatment, up to 24 months