Clinical trial NCT05236621: A Study of the Efficacy and Safety of Pomalidomide Capsules Combined With Low-Dose Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma
Official title: A Multicenter, Open-Label, Single-Arm Clinical Study of the Efficacy and Safety of Pomalidomide Capsules Combined With Low-Dose Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Multiple Myeloma
Recurrent or Refractory
Keywords: Permadomide capsules
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-02-11
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of permadomide capsules developed by Qilu Pharmaceutical Co., LTD.


Eligibility criteria: Inclusion Criteria:

1.Subjects diagnosed with multiple myeloma according to the diagnostic criteria of Chinese Multiple Myeloma Diagnosis and Treatment Guidelines (Revised in 2020); 2.Must be ≥ 18 years of age,male or female, if the subject is of childbearing age and should use effective contraceptive methods, the subject must agree to comply with all contraceptive requirements:

1. there are fertile women have to decide, at the same time take two reliable contraceptive methods (an effective contraceptive method is: tubal ligation, intrauterine contraceptive device, hormone (birth control pills, needles, patch, vaginal ring or implants) or partner vasectomy, another effective birth control method is: male or synthetic rubber condom, diaphragm or cervical cap). Unless hysterectomy is performed, effective contraception is required even if there is a history of infertility.
2. Fertile men must use rubber or synthetic condoms at all times during the use of this product and during sexual contact with fertile women within 28 days of discontinuation of this product, even if participants have successfully had a vasectomy.

3. Received at least two previous treatments (in different treatment regimens or the same regimen, including at least 2 cycles of lenalidomide and 2 cycles of proteasome inhibitors \[such as bortezomib or ixazomib\]) Relapse of multiple myeloma or ineffective to the last treatment (definition of last treatment ineffective: disease progression during the use of the treatment plan or disease progression within 60 days after the completion of the treatment plan), the last treatment plan is not limited; 4. Multiple myeloma subjects with measurable M protein, i.e., at least one of the following 3 assays:

1. Serum M protein≥0.5g/dL (5g/L);
2. Urine M protein≥200mg/24h;
3. Determination of serum free light chain: in the case of abnormal serum free light chain ratio, the level of involved free light chain is ≥10 mg/dL (100 mg/L); 5. Hematology meets the following conditions:

1) ANC≥1.0 x10\^9/L (including ANC≥1.0x10\^9/L supported by G-CSF); 2) PLT≥50 x10\^9/L； 3) When plasma cells in bone marrow ≥50%, no specific requirements for neutrophil count, platelet ≥30 x10\^9/L can be selected; 6. Liver and kidney function tests meet the following conditions:

1. TBIL ≤ 2.0mg/dL；
2. ALT、AST ≤ 3.0 x ULN； 3) Serum creatinine ≤ 3.0 mg/dL or creatinine clearance rate ≥ 30 mL/min; 7. Those who can accept and can use antithrombotic drugs, such as low molecular weight heparin sodium or aspirin; 8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2, expected survival ≥ 3 months; 9. There must be a washout period of ≥ 2 weeks (14 days) from the last treatment (excluding dexamethasone treatment); 10. Subjects voluntarily joined the study and signed a written informed consent.

Exclusion Criteria:

1. Subjects who cannot tolerate thalidomide, lenalidomide, pomalidomide and other types of drug treatment according to the judgment of the investigator.
2. Subjects who have had allergic reactions to immunomodulators similar to pomalidomide, dexamethasone or components contained in the drug;
3. Diagnosis of non-secretory MM (non-secretory subjects or subjects with a small amount of free light chain but less than 100mg/L) in multiple myeloma;
4. Subjects with active new thrombosis or unwilling to undergo antithrombotic therapy;
5. The subjects are suffering from other tumors at the same time or have a past history of tumors, or have undergone anti-tumor treatment (including major surgery) within the last 4 weeks, except for the following tumor diseases or those who have lived without tumors for ≥ 3 years so far: skin base Cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histologic findings of prostate cancer (TNM clinical stage T1a or T1b), or treated prostate cancer;
6. Subjects suffering from central nervous system diseases and requiring treatment;
7. Subjects with peripheral neuropathy ≥ grade 3;
8. Subjects who need to use immunosuppressive or steroid drugs for a long time;
9. Known subjects with hepatitis B virus (HBV-DNA ≥ 1×10\^3 copies/mL or HBV-DNA \> 200 IU/mL) or hepatitis C virus (HCV) activity, or human immunodeficiency virus (HIV) ) serologically positive;
10. Subject has any of the following:

1) According to the NYHA classification standard, cardiac insufficiency grade 2 or above; 2) Myocardial infarction occurred within one year; 3) poorly controlled angina pectoris, including variant angina pectoris; 11. Subjects have serious infectious diseases at the same time; 12. Subjects planning to become pregnant or unable to take reliable contraceptive measures; 13. Women who are pregnant or breastfeeding; 14. Subjects who have received allogeneic hematopoietic stem cell transplantation within 12 months, or who have active graft-versus-host disease (GVHD) or who require immunosuppressive therapy after 12 months of allogeneic hematopoietic stem cell transplantation； 15. Those who participated in other clinical trials and received experimental drugs within one month before the first drug use.

Primary outcomes:
measure: Total Response Rate(ORR)
timeFrame: From randomization through the study follow-up phase; up to the data cut-off of 1 December 2023; Maximum time on follow-up was 104 weeks.
Secondary outcomes:
measure: Duration of remission(DoR)
timeFrame: The time from the first observation of at least partial remission (PR) to disease progression (PD) or death from any cause is whichever comes first, assessed up to 104 weeks.
measure: Progression-free survival(PFS)
timeFrame: up to 104 weeks
measure: Overall survival(OS)
timeFrame: up to 104 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Shengjing Hospital affiliated to China Medical University
state: Beijing
city: Foshan
country: China
facility: Foshan First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guiyang
country: China
facility: Guizhou Provincial People's Hospital
state: Guizhou
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: The Third Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: Henan Tumor Hospital
state: Henan
city: Hengyang
country: China
facility: The First Affiliated Hospital of Nanhua University
state: Hunan
city: Jinan
country: China
facility: Shandong University Qilu Hospital
state: Shandong
city: Qingdao
country: China
facility: Affiliated Hospital of Qingdao University
state: Shandong
city: Weifang
country: China
facility: Weifang People's Hospital
state: Shandong
city: Weihai
country: China
facility: Weihai Central Hospital
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
state: Shanxi
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical University
state: Shanxi
city: Xi'an
country: China
facility: Second Affiliated Hospital of Xi 'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Tianjin
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University Medical College (Hematology)
state: Zhejiang
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Wenming Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Juan Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Hongmei Jing, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Huo Tan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangzhou First People's Hospital
name: Shunqing Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: First People's Hospital of Foshan
name: Ying Zhao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yunnan Cancer Hospital
name: Xun Lai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guizhou Provincial People's Hospital
name: Qing Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hebei Medical University Third Hospital
name: Jinqiao Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hebei Medical University Fourth Hospital
name: Lihong Liu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Henan Tumor Hospital
name: Baijun Fang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Nanhua University
name: Junjun Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weihai Central Hospital
name: Binghua Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shengjing Hospital
name: Wei Yang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital of Qingdao University
name: Wei Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong University Qilu Hospital
name: Ming Hou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital of Xi 'an Jiaotong University
name: Aili He, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Cancer Hospital
name: Yafei Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Zhejiang University Medical College (Hematology)
name: Jie Jin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weifang People's Hospital
name: Xuehong Ran, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sichuan Provincial People's Hospital
name: Jiao Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanxi Province Cancer Hospital
name: Liping Su, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Hospital of Shanxi Medical University
name: Yanping Ma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xi 'an Central Hospital
name: Yanping Song, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhangzhou Hospital, Fujian Province
name: Congmeng Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan Hospital Xiamen University
name: Quanyi Lu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital of Inner Mongolia Medical University
name: Da Gao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Gannan Medical College
name: Wenhong Lai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Xinjiang Medical University
name: Jianping Hao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Liaocheng People's Hospital
name: Taiwu Xiao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Zhejiang University Medical College (Transplant Center)
name: Zhen Cai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuxi People's Hospital
name: Xin Zhou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: