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

  • STATUS
    Recruiting
  • End date
    Sep 27, 2025
  • participants needed
    167
  • sponsor
    BeiGene
Updated on 27 May 2022

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.

Details
Condition Relapsed/Refractory Multiple Myeloma
Treatment Dexamethasone, Carfilzomib, BGB-11417, BGB-11417 + Dexamethasone, BGB-11417 + Dexamethasone + Carfilzomib
Clinical Study IdentifierNCT04973605
SponsorBeiGene
Last Modified on27 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
A confirmed diagnosis of multiple myeloma (must have an M-component in serum and/or urine)
Measurable disease defined as
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 κ:λ ratio
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
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
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
Participant has documented relapsed or progressive MM on or after any regimen or who are refractory to the most recent line of therapy
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
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
achieve minimal response or development of progressive disease) while on
primary or salvage therapy or progresses within 60 days of last therapy
Positivity for t(11;14) by validated fluorescence in situ hybridization (FISH) testing
assay in a pre-defined laboratory
fresh bone marrow aspirate sample must be collected at screening and sent to central laboratory for t(11;14) FISH testing
Adequate organ function defined as
Hemoglobin ≥ 8.0 g/dL, within 7 days before first dose of study treatment, independent of growth factor support and transfusions
Platelet count ≥ 75,000/μL, within 7 days before first dose of study treatment, independent of growth factor support and transfusions
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
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

Exclusion Criteria

Non secretory MM (Serum free light chains < 10 mg/dL)
Solitary plasmacytoma
Active plasma cell leukemia (ie, either 20% of peripheral white blood cells or > 2.0 x 109/L circulating plasma cells by standard differential)
Waldenström macroglobulinemia
Amyloidosis
Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome
Uncontrolled diabetes (HbA1c > 7% or 53 mmol/mol or requiring insulin at study entry
Chronic respiratory disease that requires continuous oxygen
Participant has any of the following conditions
Myocardial infarction ≤ 6 months before screening
Significant cardiovascular disease, including but not limited to
Ejection fraction ≤ 50%
Unstable angina≤ 3 months before screening
New York Heart Association Class III or IV congestive heart failure
History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
Heart rate-corrected QT interval > 480 milliseconds based on Fridericia's formula
History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place
Uncontrolled hypertension at screening, defined as systolic blood pressure > 170 mmHg and diastolic blood pressure > 105 mmHg by ≥ 2 consecutive measurements
Known infection with human immunodeficiency virus (HIV)
Serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows
Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Participants with presence of HBcAb, but absence of HBsAg, are eligible if HBV DNA is undetectable (limitation of sensitivity < 20 IU/mL) ,), and if they are willing to undergo monthly monitoring for HBV reactivation
Presence of HCV antibody. Participants with presence of HCV antibody are eligible if HCV RNA is undetectable (limitation of sensitivity < 15 IU/mL)
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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