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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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 κ:λ 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. 1. 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. 2. 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. 3. 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. 5. 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. 6. Adequate organ function defined as: 1. Hemoglobin ≥ 8.0 g/dL, within 7 days before first dose of study treatment, independent of growth factor support and transfusions. 2. Platelet count ≥ 75,000/μL, within 7 days before first dose of study treatment, independent of growth factor support and transfusions. 3. 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. 4. 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:

1. Participant has any of the following conditions: 1. Non secretory MM (Serum free light chains < 10 mg/dL) 2. Solitary plasmacytoma. 3. Active plasma cell leukemia (ie, either 20% of peripheral white blood cells or > 2.0 x 109/L circulating plasma cells by standard differential) 4. Waldenström macroglobulinemia. 5. Amyloidosis. 6. Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome. 7. Uncontrolled diabetes (HbA1c > 7% or 53 mmol/mol or requiring insulin at study entry. 8. Chronic respiratory disease that requires continuous oxygen. 2. Significant cardiovascular disease, including but not limited to: 1. Myocardial infarction ≤ 6 months before screening. 2. Ejection fraction ≤ 50% 3. Unstable angina≤ 3 months before screening. 4. New York Heart Association Class III or IV congestive heart failure. 5. History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes) 6. Heart rate-corrected QT interval > 480 milliseconds based on Fridericia's formula. 7. History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place. 8. Uncontrolled hypertension at screening, defined as systolic blood pressure > 170 mmHg and diastolic blood pressure > 105 mmHg by ≥ 2 consecutive measurements. 3. Known infection with human immunodeficiency virus (HIV) 4. Serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows: 1. 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. 2. 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04973605
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

BeiGene
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Brazil, Canada, China, Korea, Republic of, New Zealand, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Relapsed/Refractory Multiple Myeloma
Arms & Interventions

Arms

Experimental: Part 1 Dose Escalation

Dose-escalation and de-escalation to determine maximum tolerated dose (MTD)

Experimental: Part 2 Cohort Expansion

There will be 5 expansion cohorts to further evaluate the safety and efficacy of BGB-11417

Interventions

Drug: - BGB-11417

Administered orally daily

Drug: - Dexamethasone

Once weekly either orally or intravenously

Drug: - Carfilzomib

Administered intravenously weekly

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Recruiting

Address

University of Alabama At Birmingham Hospital

Birmingham, Alabama, 35294

City of Hope National Medical Center, Duarte, California

Status

Recruiting

Address

City of Hope National Medical Center

Duarte, California, 91010

City of Hope At Irvine Lennar, Irvine, California

Status

Recruiting

Address

City of Hope At Irvine Lennar

Irvine, California, 92618

Valkyrie Clinical Trials, Los Angeles, California

Status

Recruiting

Address

Valkyrie Clinical Trials

Los Angeles, California, 90067

University of Miami, Miami, Florida

Status

Recruiting

Address

University of Miami

Miami, Florida, 33136

Tampa General Hospital, Tampa, Florida

Status

Recruiting

Address

Tampa General Hospital

Tampa, Florida, 33606

University of Illinois Cancer Center, Chicago, Illinois

Status

Recruiting

Address

University of Illinois Cancer Center

Chicago, Illinois, 60612

Springfield, Illinois

Status

Recruiting

Address

Southern Illinois University School of Medicine

Springfield, Illinois, 62629

Annapolis, Maryland

Status

Recruiting

Address

Luminis Health Anne Arundel Medical Center

Annapolis, Maryland, 21401

Maryland Oncology Hematology, Pa, Columbia, Maryland

Status

Recruiting

Address

Maryland Oncology Hematology, Pa

Columbia, Maryland, 21044

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Emory University Winship Cancer Center, Detroit, Michigan

Status

Recruiting

Address

Emory University Winship Cancer Center

Detroit, Michigan, 30322

Karmanos Cancer Institute, Detroit, Michigan

Status

Recruiting

Address

Karmanos Cancer Institute

Detroit, Michigan, 48201

New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York, 10065

Columbus, Ohio

Status

Recruiting

Address

The James Cancer Hospital and Solove Research Institute At Ohio State University

Columbus, Ohio, 43210

Huntsman Cancer Institute, Salt Lake City, Utah

Status

Recruiting

Address

Huntsman Cancer Institute

Salt Lake City, Utah, 19104

University of Washington, Seattle, Washington

Status

Recruiting

Address

University of Washington

Seattle, Washington, 98195

Madison, Wisconsin

Status

Recruiting

Address

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792

Medical College of Wisconsin, Milwaukee, Wisconsin

Status

Recruiting

Address

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

International Sites

Nepean Hospital, Kingswood, New South Wales, Australia

Status

Recruiting

Address

Nepean Hospital

Kingswood, New South Wales, 2747

Monash Health, Clayton, Victoria, Australia

Status

Recruiting

Address

Monash Health

Clayton, Victoria, 3168

St Vincents Hospital Melbourne, Fitzroy, Victoria, Australia

Status

Recruiting

Address

St Vincents Hospital Melbourne

Fitzroy, Victoria, 3065

The Alfred Hospital, Melbourne, Victoria, Australia

Status

Recruiting

Address

The Alfred Hospital

Melbourne, Victoria, 3004

Royal Perth Hospital, Perth, Western Australia, Australia

Status

Recruiting

Address

Royal Perth Hospital

Perth, Western Australia, 6000

Hospital Sirio Libanes Brasilia, Brasilia, Brazil

Status

Recruiting

Address

Hospital Sirio Libanes Brasilia

Brasilia, , 70200-730

Brasilia, Brazil

Status

Recruiting

Address

Instituto Dor de Pesquisa E Ensino Distrito Federal

Brasilia, , 70390140

Porto Alegre, Brazil

Status

Recruiting

Address

Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

Porto Alegre, , 90850-170

Sao Paulo, Brazil

Status

Recruiting

Address

Instituto Dor de Pesquisa E Ensino Sao Paulo

Sao Paulo, , 01401-002

Hospital Nove de Julho Dasa, Sao Paulo, Brazil

Status

Recruiting

Address

Hospital Nove de Julho Dasa

Sao Paulo, , 01409-902

Accamargo Cancer Center, Sao Paulo, Brazil

Status

Recruiting

Address

Accamargo Cancer Center

Sao Paulo, , 01508-010

Clinica Sao Germano, Sao Paulo, Brazil

Status

Recruiting

Address

Clinica Sao Germano

Sao Paulo, , 04537-080

Sao Paulo, Brazil

Status

Recruiting

Address

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

Sao Paulo, , 05653-120

Cross Cancer Institute, Edmonton, Alberta, Canada

Status

Recruiting

Address

Cross Cancer Institute

Edmonton, Alberta, T6G1Z2

Vancouver, British Columbia, Canada

Status

Recruiting

Address

British Columbia Cancer Agency the Vancouver Centre

Vancouver, British Columbia, V5Z 4E6

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Status

Recruiting

Address

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C9

Jewish General Hospital, Montreal, Quebec, Canada

Status

Recruiting

Address

Jewish General Hospital

Montreal, Quebec, QC H3t 1E2

Beijing Chao Yang Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Beijing Chao Yang Hospital

Beijing, Beijing, 100020

Peking University Peoples Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Peking University Peoples Hospital

Beijing, Beijing, 100044

Chongqing Cancer Hospital, Chongqing, Chongqing, China

Status

Recruiting

Address

Chongqing Cancer Hospital

Chongqing, Chongqing, 400030

Fujian Medical University Union Hospital, Fuzhou, Fujian, China

Status

Recruiting

Address

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001

Sun Yat Sen University Cancer Center, Guangzhou, Guangdong, China

Status

Recruiting

Address

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, 510060

Shijiazhuang, Hebei, China

Status

Recruiting

Address

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000

Henan Cancer Hospital, Zhengzhou, Henan, China

Status

Recruiting

Address

Henan Cancer Hospital

Zhengzhou, Henan, 450000

Zhengzhou, Henan, China

Status

Recruiting

Address

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052

Hunan Cancer Hospital, Changsha, Hunan, China

Status

Recruiting

Address

Hunan Cancer Hospital

Changsha, Hunan, 410013

Nanchang, Jiangxi, China

Status

Recruiting

Address

The First Affiliated Hospital of Nanchang University Branch Xianghu

Nanchang, Jiangxi, 332000

Shenyang, Liaoning, China

Status

Recruiting

Address

The First Hospital of China Medical University

Shenyang, Liaoning, 110001

Qingdao Municipal Hospital, Qingdao, Shandong, China

Status

Recruiting

Address

Qingdao Municipal Hospital

Qingdao, Shandong, 266000

Shanghai, Shanghai, China

Status

Recruiting

Address

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai, 200032

Shanghai, Shanghai, China

Status

Recruiting

Address

Shanghai Fourth Peoples Hospital Affiliated to Tongji University

Shanghai, Shanghai, 200434

Tianjin, Tianjin, China

Status

Recruiting

Address

Tianjin Medical University General Hospital

Tianjin, Tianjin, 300052

Hangzhou, Zhejiang, China

Status

Recruiting

Address

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003

Seoul National University Hospital, Seoul, Seoul Teugbyeolsi, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 03080

Seoul, Seoul Teugbyeolsi, Korea, Republic of

Status

Recruiting

Address

Severance Hospital Yonsei University Health System

Seoul, Seoul Teugbyeolsi, 03722

Asan Medical Center, Seoul, Seoul Teugbyeolsi, Korea, Republic of

Status

Recruiting

Address

Asan Medical Center

Seoul, Seoul Teugbyeolsi, 05505

Samsung Medical Center, Seoul, Seoul Teugbyeolsi, Korea, Republic of

Status

Recruiting

Address

Samsung Medical Center

Seoul, Seoul Teugbyeolsi, 06351

Seoul, Seoul Teugbyeolsi, Korea, Republic of

Status

Recruiting

Address

The Catholic University of Korea, Seoul St Marys Hospital

Seoul, Seoul Teugbyeolsi, 06591

Aotearoa Clinical Trials, Auckland, New Zealand

Status

Recruiting

Address

Aotearoa Clinical Trials

Auckland, , 2025

University College Hospital, London, United Kingdom

Status

Recruiting

Address

University College Hospital

London, , NW1 2PG

Sutton, United Kingdom

Status

Recruiting

Address

Royal Marsden Nhs Foundation Royal Marsden Hospital

Sutton, , SM2 5PT

Royal Cornwall Hospitalsnhs Trust, Truro, United Kingdom

Status

Recruiting

Address

Royal Cornwall Hospitalsnhs Trust

Truro, , TR1 3LJ