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

NCT05236621 | Unknown Phase 3 DMC

• 1 other identifier: QL-YK4-056-003
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 23

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

Keywords

Permadomide capsules

Outcome Measures

Primary Outcomes (1)

• Total Response Rate(ORR)

  Statistical analysis of ORR of primary efficacy will be based on IRC remission assessment results, as well as the investigator's remission assessment.Strict Complete Response (sCR) + Complete Response (CR) + Partial Response (PR) + Very Good PR (VGPR).

  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 (3)

• Duration of remission(DoR)

  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.

• Progression-free survival(PFS)

  up to 104 weeks

• Overall survival(OS)

  up to 104 weeks

Study Arms (1)

Permadomide + Low-Dose Dexamethasone

EXPERIMENTAL

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.

Drug: Pomalidomide; Drug: Dexamethasone

Interventions

Pomalidomide DRUG

4 mg pomalidomide capsules administered orally

Permadomide + Low-Dose Dexamethasone

Dexamethasone DRUG

40 mg dexamethasone tablets administered orally

Permadomide + Low-Dose Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• 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.
• \. 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:
• Serum M protein≥0.5g/dL (5g/L);
• Urine M protein≥200mg/24h;
• 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:
• \) 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:
• TBIL ≤ 2.0mg/dL；
• 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.

You may not qualify if:

• Subjects who cannot tolerate thalidomide, lenalidomide, pomalidomide and other types of drug treatment according to the judgment of the investigator.
• Subjects who have had allergic reactions to immunomodulators similar to pomalidomide, dexamethasone or components contained in the drug;
• 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;
• Subjects with active new thrombosis or unwilling to undergo antithrombotic therapy;
• 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;
• Subjects suffering from central nervous system diseases and requiring treatment;
• Subjects with peripheral neuropathy ≥ grade 3;
• Subjects who need to use immunosuppressive or steroid drugs for a long time;
• 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;
• Subject has any of the following:
• \) 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (23)

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China

Location

Shengjing Hospital affiliated to China Medical University

Beijing, Beijing Municipality, 100000, China

Location

Foshan First People's Hospital

Foshan, Guangdong, 528000, China

Location

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510000, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Guizhou Provincial People's Hospital

Guiyang, Guizhou, 550000, China

Location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Henan Tumor Hospital

Zhengzhou, Henan, 450000, China

Location

The First Affiliated Hospital of Nanhua University

Hengyang, Hunan, 421200, China

Location

Shandong University Qilu Hospital

Jinan, Shandong, 250000, China

Location

Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

Weifang People's Hospital

Weifang, Shandong, 261000, China

Location

Weihai Central Hospital

Weihai, Shandong, 264200, China

Location

Shanxi Cancer Hospital

Taiyuan, Shanxi, 030000, China

Location

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

Second Affiliated Hospital of Xi 'an Jiaotong University

Xi’an, Shanxi, 710000, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610000, China

Location

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300000, China

Location

Yunnan Cancer Hospital

Kunming, Yunnan, 650000, China

Location

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

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

• 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.

  PMID: 38112795 DERIVED

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

pomalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Wenming Chen, MD, PhD

  Beijing Chao Yang Hospital

  PRINCIPAL INVESTIGATOR

• Juan Li, MD, PhD

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Hongmei Jing, MD, PhD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

• Huo Tan, MD, PhD

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

• Shunqing Wang, MD, PhD

  Guangzhou First People's Hospital

  PRINCIPAL INVESTIGATOR

• Ying Zhao, MD, PhD

  First People's Hospital of Foshan

  PRINCIPAL INVESTIGATOR

• Xun Lai, MD, PhD

  Yunnan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Qing Wang, MD, PhD

  Guizhou Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Jinqiao Zhang, MD, PhD

  Hebei Medical University Third Hospital

  PRINCIPAL INVESTIGATOR

• Lihong Liu, MD, PhD

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

• Baijun Fang, MD, PhD

  Henan Tumor Hospital

  PRINCIPAL INVESTIGATOR

• Junjun Li, MD, PhD

  The First Affiliated Hospital of Nanhua University

  PRINCIPAL INVESTIGATOR

• Binghua Wang, MD, PhD

  Weihai Central Hospital

  PRINCIPAL INVESTIGATOR

• Wei Yang, MD, PhD

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

• Wei Wang, MD, PhD

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

• Ming Hou, MD, PhD

  Shandong University Qilu Hospital

  PRINCIPAL INVESTIGATOR

• Aili He, MD, PhD

  Second Affiliated Hospital of Xi 'an Jiaotong University

  PRINCIPAL INVESTIGATOR

• Yafei Wang, MD, PhD

  Tianjin Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Jie Jin, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Xuehong Ran, MD, PhD

  Weifang People's Hospital

  PRINCIPAL INVESTIGATOR

• Jiao Chen, MD, PhD

  Sichuan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Liping Su, MD, PhD

  Shanxi Province Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Yanping Ma, MD, PhD

  Second Hospital of Shanxi Medical University

  PRINCIPAL INVESTIGATOR

• Yanping Song, MD, PhD

  Xi 'an Central Hospital

  PRINCIPAL INVESTIGATOR

• Congmeng Lin, MD, PhD

  Zhangzhou Hospital, Fujian Province

  PRINCIPAL INVESTIGATOR

• Quanyi Lu, MD, PhD

  Zhongshan Hospital Xiamen University

  PRINCIPAL INVESTIGATOR

• Da Gao, MD, PhD

  The Affiliated Hospital of Inner Mongolia Medical University

  PRINCIPAL INVESTIGATOR

• Wenhong Lai, MD, PhD

  The First Affiliated Hospital of Gannan Medical College

  PRINCIPAL INVESTIGATOR

• Jianping Hao, MD, PhD

  First Affiliated Hospital of Xinjiang Medical University

  PRINCIPAL INVESTIGATOR

• Taiwu Xiao, MD, PhD

  Liaocheng People's Hospital

  PRINCIPAL INVESTIGATOR

• Zhen Cai, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Xin Zhou, MD, PhD

  Wuxi People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 11, 2022
• Study Start: January 4, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2023
• Last Updated: February 11, 2022

Record last verified: 2022-02

Locations

CN (23)