A Study of the Efficacy and Safety of Pomalidomide Capsules Combined With Low-Dose Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma

NCT ID: NCT05236621

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-04
• Study Completion Date: 2023-12-31

Brief Summary

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

Conditions

Multiple Myeloma; Recurrent or Refractory

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Permadomide + Low-Dose Dexamethasone

Participants received 4 mg pomalidomide administered by mouth on Days 1 to 21 of each 28-day treatment cycle and 40 mg dexamethasone administered by mouth once per day on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression.

Group Type: EXPERIMENTAL

Pomalidomide

Intervention Type: DRUG

4 mg pomalidomide capsules administered orally

Dexamethasone

Intervention Type: DRUG

40 mg dexamethasone tablets administered orally

Interventions

Pomalidomide

4 mg pomalidomide capsules administered orally

Intervention Type: DRUG

Dexamethasone

40 mg dexamethasone tablets administered orally

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wenming Chen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital

Juan Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Hongmei Jing, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Huo Tan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Guangzhou Medical University

Shunqing Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Guangzhou First People's Hospital

Ying Zhao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

First People's Hospital of Foshan

Xun Lai, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yunnan Cancer Hospital

Qing Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Guizhou Provincial People's Hospital

Jinqiao Zhang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hebei Medical University Third Hospital

Lihong Liu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hebei Medical University Fourth Hospital

Baijun Fang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Henan Tumor Hospital

Junjun Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Nanhua University

Binghua Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Weihai Central Hospital

Wei Yang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Wei Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Qingdao University

Ming Hou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shandong University Qilu Hospital

Aili He, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Xi 'an Jiaotong University

Yafei Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Cancer Hospital

Jie Jin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhejiang University Medical College (Hematology)

Xuehong Ran, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Weifang People's Hospital

Jiao Chen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sichuan Provincial People's Hospital

Liping Su, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanxi Province Cancer Hospital

Yanping Ma, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Hospital of Shanxi Medical University

Yanping Song, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Xi 'an Central Hospital

Congmeng Lin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhangzhou Hospital, Fujian Province

Quanyi Lu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Hospital Xiamen University

Da Gao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Inner Mongolia Medical University

Wenhong Lai, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Gannan Medical College

Jianping Hao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Xinjiang Medical University

Taiwu Xiao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Liaocheng People's Hospital

Zhen Cai, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhejiang University Medical College (Transplant Center)

Xin Zhou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wuxi People's Hospital

Locations

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Shengjing Hospital affiliated to China Medical University

Beijing, Beijing Municipality, China

Foshan First People's Hospital

Foshan, Guangdong, China

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Henan Tumor Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Nanhua University

Hengyang, Hunan, China

Shandong University Qilu Hospital

Jinan, Shandong, China

Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Weifang People's Hospital

Weifang, Shandong, China

Weihai Central Hospital

Weihai, Shandong, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Second Affiliated Hospital of Xi 'an Jiaotong University

Xi’an, Shanxi, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

The First Affiliated Hospital of Zhejiang University Medical College (Hematology)

Hangzhou, Zhejiang, China

Countries

China

References

Zhou H, Wang Y, Chen J, He A, Jin J, Lu Q, Zhao Y, Li J, Hou M, Su L, Lai X, Wang W, Liu L, Ma Y, Gao D, Lai W, Zhou X, Jing H, Zhang J, Yang W, Ran X, Lin C, Hao J, Xiao T, Huang Z, Zhu Z, Wang Q, Fang B, Wang B, Song Y, Cai Z, Liu B, Zhu Y, Yang X, Kang X, Li J, Chen W. Efficacy and safety of generic pomalidomide plus low-dose dexamethasone in relapsed or refractory multiple myeloma: a multicenter, open-label, single-arm trial. Ann Hematol. 2024 Mar;103(3):855-868. doi: 10.1007/s00277-023-05558-y. Epub 2023 Dec 19.

Reference Type: DERIVED

PMID: 38112795 (View on PubMed)

Other Identifiers

QL-YK4-056-003

Identifier Type: -

Identifier Source: org_study_id