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A Phase 1b/2 Study of BGB-11417in Monotherapy and in Various Combinations With Dexamethasone and Carfilzomib in Multiple Myeloma

Status
Active
Cancer Type
Multiple Myeloma
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04973605
Protocol IDs
BGB-11417-105 (primary)
NCI-2022-07236
2021-003614-39
U1111-1277-5444
Study Sponsor
BeiGene
NCI Full Details
http://clinicaltrials.gov/show/NCT04973605

Summary

Study consists of two parts, a part 1 dose escalation and a part 2 cohort expansion in
combination with dexamethasone and carfilzomib intravenously across two cohorts with a
monotherapy component as well.

Eligibility

  1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  2. A confirmed diagnosis of multiple myeloma (must have an M-component in serum and/or urine)
  3. Measurable disease defined as: i. M-spike = 500mg/dL, or ii. Urine protein M-spike of = 200 mg/day, or iii. Serum free light chains = 10 mg/dL, and an abnormal ?:? ratio
  4. Participant has documented relapsed or progressive MM on or after any regimen or who are refractory to the most recent line of therapy. i. Relapsed MM is defined as previously treated MM that progresses and requires initiation of salvage therapy but does not meet the criteria for refractory MM. ii. Refractory MM is defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease) while on primary or salvage therapy or progresses within 60 days of last therapy.
  5. Participants in Part 1 should have failed all other available options including having had = 3 prior lines of therapy including a proteasome inhibitor, IMiD agent, and an anti-CD38 monoclonal antibody.
  6. Participants in Part 2 should have had and failed = 1 but = 7 prior lines of therapy and will have had prior treatment with both a proteasome inhibitor and an IMiD agent. Note: A line of therapy consists of greater = 1 complete cycle of a single agent, a regimen consisting of combination of several drugs, or a planned sequential therapy of various regimens. Induction therapy with consolidation and maintenance following stem cell transplant is considered a single line of therapy.
  7. Prior treatment with carfilzomib is allowed but the patient must not be considered carfilzomib refractory and not have had carfilzomib within the past 6 months
  8. Positivity for t(11;14) by validated fluorescence in situ hybridization (FISH) testing assay in a pre-defined laboratory a. fresh bone marrow aspirate sample must be collected at screening and sent to central laboratory for t(11;14) FISH testing.
  9. Adequate organ function defined as:
  10. Hemoglobin = 8.0 g/dL, within 7 days before first dose of study treatment, independent of growth factor support and transfusions
  11. Platelet count = 75,000/µL, within 7 days before first dose of study treatment, independent of growth factor support and transfusions
  12. Absolute neutrophil count (ANC) = 1000/mm3 [ANC = (% of segmented neutrophils + % of segmented bands) x total WBC count within 7 days before first dose of study treatment
  13. ALT and AST = 3 x upper limit of normal (ULN) and total bilirubin = 2.0 x ULN Serum creatinine = 1.5 x ULN or creatinine clearance = 45 mL/min/1.73 m2 calculated by the MDRD-6 formula.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.