TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

July 2, 2024 updated by: TJ Biopharma Co., Ltd.

A Phase 3, Randomized, Open-label, Parallel-controlled, Multi-center Study Comparing TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma Who Received at Least 1 Prior Line of Treatment

A phase 3, randomized, open-label, parallel-controlled, multi-center study comparing TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in subjects with relapsed or refractory multiple myeloma who received at least 1 prior line of treatment

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
289

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100020
        • Capital Medical University (CMU) - Beijing Chao-Yang Hospital
      • Beijing, Beijing, China, 100083
        • Peking University Third Hospital
      • Beijing, Beijing, China
        • Capital Medical University (CMU) - Beijing Chao-Yang Hospital
    • Bengbu
      • Bengbu, Bengbu, China
        • The First Affiliated Hospital of Bengbu Medical College
    • Changchun
      • Jilin, Changchun, China, 130021
        • The First Bethune Hospital of Jilin University
    • Changsha
      • Hunan, Changsha, China
        • Hunan Cancer Hospital
    • Fuzhou
      • Fujian, Fuzhou, China, 350001
        • Fujian Medical University Union Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital, Sun Yat-sen University
    • Guangzhou
      • Guangdong, Guangzhou, China, 510060
        • Sun Yat-Sen University Cancer Center
      • Guangdong, Guangzhou, China, 510080
        • Guangdong General Hospital
      • Guangdong, Guangzhou, China, 510180
        • Guangzhou First People's Hospital
      • Guangdong, Guangzhou, China, 510515
        • Nanfang Hospital
    • Hangzhou
      • Zhejiang, Hangzhou, China, 310003
        • The First Affiliated Hospital of Zhejiang University
      • Zhejiang, Hangzhou, China
        • The First Affiliated Hospital of Zhejiang University
    • Hubei
      • Wuhan, Hubei, China
        • Hubei Cancer Hospital
    • Jiangsu
      • Nantong, Jiangsu, China
        • Affiliated Hospital of Nantong University
    • Kaohsiung
      • Taiwan, Kaohsiung, China, 833
        • Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital
    • Kunming
      • Yunnan, Kunming, China, 650101
        • The Second Affiliated Hospital of Kunming Medical University
      • Yunnan, Kunming, China, 650221
        • The First People's Hospital of Yunnan Province
    • Lanzhou
      • Lanzhou, Lanzhou, China, 730000
        • The First Hospital of Lanzhou University
      • Lanzhou, Lanzhou, China, 730030
        • Lanzhou university second hospital
    • Nanchang
      • Jiangxi, Nanchang, China, 330006
        • Second Affiliated Hospital of Nanchang University
    • Nanjing
      • Nanjing, Nanjing, China, 210008
        • Nanjing Drum Tower Hospital
      • Nanjing, Nanjing, China, 210029
        • Jiangsu Province Hospital
    • Nanning
      • Guangxi, Nanning, China, 530021
        • Guangxi Medical Univ. 1st Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200233
        • Shanghai Sixth People's Hospital
      • Shanghai, Shanghai, China, 200000
        • Shanghai Changzheng Hospital
      • Shanghai, Shanghai, China, 200025
        • Shanghai Jiao Tong University School of Medicine - Ruijin Hospital
    • Shenyang
      • Shenyang, Shenyang, China, 110001
        • The First Hospital of China Medical University
    • Shenzhen
      • Guangdong, Shenzhen, China, 518035
        • Shenzhen Second Hospital
    • Suzhou
      • Suzhou, Suzhou, China, 215006
        • The First Affiliated Hospital of Soochow University
    • Taibei
      • Taiwan, Taibei, China, 100
        • National Taiwan University Hospital
    • Taichung
      • Taiwan, Taichung, China, 40705
        • Taichung Veterans General Hospital
    • Taipei
      • Taiwan, Taipei, China, 114
        • Tri-Service General Hospital
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Tianjin Medical University General Hospital
      • Tianjin, Tianjin, China, 300060
        • Tianjin Cancer Hospital
    • Wenzhou
      • Zhejiang, Wenzhou, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
    • Wuhan
      • Hubei, Wuhan, China, 430014
        • The Central Hospital of Wuhan
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
    • Zhengzhou
      • Henan, Zhengzhou, China, 450008
        • Henan Cancer Hospital
  • Taiwan
      • Taipei, Taiwan
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18, male or female;
  2. Subjects must have had documented MM;
  3. At the screening phase, subject must have one or more measurable disease;
  4. Subjects must have received at least 1 prior line treatment* for relapsed or refractor MM;
  5. Subjects who are in a state of progressive disease (PD);
  6. Subjects must have life expectancy of no less than 6 months;
  7. Subjects must have an ECOG (Eastern Cooperative Oncology Group) performance status score of 0~2;
  8. A woman of child-bearing potential must have a negative serum pregnancy test within 14 days prior to the first study agent administration, and a negative urine pregnancy test on the day of the first study agent administration; as well as those should avoid sexual intercourse with the opposite sex or should adopt two reliable methods of contraception at the same time during the study period. A woman of child-bearing potential is required to take effective contraceptive measures throughout this study and within 6 months after the last dosing; female subjects must agree not to donate any eggs for the purpose of assisted reproduction throughout this study and within 6 months after completion of this study;
  9. Male subjects who are sexually active with women of child-bearing potential and have not undergone vasoligation must agree to use barrier methods of birth control, or that their partners use block caps (cervical cap or dome cap), spermicidal foam, contraceptive gel, contraceptive diaphragm, contraceptive cream, or suppository, and all male subjects are not allowed to donate sperms throughout this study and within 6 months after the last dosing;
  10. Subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study;
  11. Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.

Exclusion Criteria:

  1. Subject has received anti-CD38 monoclonal antibody treatment previously;
  2. Subject has received CAR-T cell therapy previously;
  3. Subject has previously received allogenic stem cell transplant, or subject has received autologous stem cell transplant within 3 months before administration of the study agent;
  4. Primary refractory multiple myeloma;
  5. Subject's disease shows evidence of resistance to lenalidomide;
  6. Subject's disease shows evidence of intolerance to lenalidomide;
  7. Subject is exhibiting clinical signs of central nervous system (CNS) involvement of MM;
  8. Subjects with known moderate or severe persistent asthma within the past 5 years;
  9. Subject has active hepatitis B or C virus infection15. Subject is seropositive for human immunodeficiency virus (HIV);
  10. Subject has clinically significant cardiac disease;
  11. Subject has known allergies, hypersensitivity, or intolerance to lenalidomide, corticosteroids, monoclonal antibodies or human proteins, or their excipients or known sensitivity to mammalian-derived products;
  12. Subject with known or suspicious conditions that would lead to failure to abide by the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TJ202, Lenalidomide and Dexamethasone
Drug: TJ202, Lenalidomide and Dexamethasone
One dose of TJ202 will be given on Day 1 and Day 4 of Week 1, respectively, every week from Week 2 to Week 12, every 2 weeks from Week 13 to Week 24 and then every 4 weeks thereafter.Lenalidomide 25mg will be administered orally on Days 1 through 21 of each 28-days cycle.Dexamethasone 40 mg will be administered on Day 1 and Day 4 of Week 1, respectively and then 40mg weekly thereafter.
Active Comparator: Lenalidomide and Dexamethasone
Drug: Lenalidomide and Dexamethasone
Lenalidomide 25mg will be administered orally on Days 1 through 21 of each 28-days cycle.Dexamethasone 40 mg weekly will be administered.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 18.4 months(Active) 30.7 months(experimental)
defined as the duration from the date of randomization to either PD, according to the IMWG criteria, or death, whichever occurs first
18.4 months(Active) 30.7 months(experimental)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TJ Biopharma Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TJ202001MMY301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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