Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04280328|
Recruitment Status : Recruiting
First Posted : February 21, 2020
Last Update Posted : September 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Ciforadenant Drug: daratumumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma|
|Actual Study Start Date :||February 20, 2020|
|Estimated Primary Completion Date :||February 7, 2023|
|Estimated Study Completion Date :||July 15, 2025|
Experimental: Ciforadenant in combination with daratumumab
Ciforadenant 100 mg orally twice daily in combination with daratumumab IV 16 mg/kg.
100 mg orally twice daily for 28-day cycles
Other Name: CPI-444
16 mg/kg administered intravenously as follows based on 28-day cycles:
- 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
- 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]).
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04280328
|Contact: Clinical Operations||650-900-4520||CPI444003inquiry@corvuspharma.com|
|United States, Maryland|
|The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Recruiting|
|Baltimore, Maryland, United States, 21231|
|Contact: J Law 650-900-4558 CPI444003inquiry@corvuspharma.com|
|Principal Investigator: Philip Imus, MD|
|Study Director:||M Mobasher, MD, MPH||Corvus Pharmaceuticals|