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Completed

NCT Number: NCT04280328

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ciforadenant

Drug

100 mg orally twice daily for 28-day cycles

Other names: CPI-444

Daratumumab

Drug

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Overall response rate.

    Time frame: From start of treatment to end of treatment, up to 24 months

    According to international myeloma working group guidelines (including stringent complete response [sCR], complete response [CR], very good partial response [VGPR], partial response [PR]).

  2. Duration of response.

    Time frame: From start of treatment to end of treatment, up to 24 months

    Time from the first assessment showing objective response to the date of documented disease progression.

  3. Disease control rate.

    Time frame: From start of treatment to end of treatment, up to 24 months

    Proportion of participants achieving disease control for ≥ 3 months.

  4. Time to next therapy.

    Time frame: Up to 2 years after end of treatment.

    Time from end of treatment to starting next anti-myeloma therapy.

  5. Progression free survival.

    Time frame: Up to 2 years after end of treatment.

    Proportion of participants remaining progression free or surviving at a given time.

  6. Minimal Residual Disease.

    Time frame: From start of treatment to end of treatment, up to 24 months

    Rate of molecular minimal residual disease (MRD) negativity.

Sponsors and collaborators

Lead sponsor

Corvus Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 21, 2020
Registry last updated
Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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