TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
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| ClinicalTrials.gov Identifier: NCT03952091 |
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Recruitment Status :
Active, not recruiting
First Posted : May 16, 2019
Last Update Posted : October 18, 2022
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Sponsor:
I-Mab Biopharma Co. Ltd.
Information provided by (Responsible Party):
I-Mab Biopharma Co. Ltd.
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Brief Summary:
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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma in Relapse Refractory Multiple Myeloma | Drug: TJ202, Lenalidomide and Dexamethasone Drug: Lenalidomide and Dexamethasone | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 291 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | March 27, 2019 |
| Estimated Primary Completion Date : | May 31, 2024 |
| Estimated Study Completion Date : | May 31, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
| Arm | Intervention/treatment |
|---|---|
| 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. |
Primary Outcome Measures :
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥ 18, male or female;
- Subjects must have had documented MM;
- At the screening phase, subject must have one or more measurable disease;
- Subjects must have received at least 1 prior line treatment* for relapsed or refractor MM;
- Subjects who are in a state of progressive disease (PD);
- Subjects must have life expectancy of no less than 6 months;
- Subjects must have an ECOG (Eastern Cooperative Oncology Group) performance status score of 0~2;
- 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;
- 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;
- 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;
- Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
Exclusion Criteria:
- Subject has received anti-CD38 monoclonal antibody treatment previously;
- Subject has received CAR-T cell therapy previously;
- 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;
- Primary refractory multiple myeloma;
- Subject's disease shows evidence of resistance to lenalidomide;
- Subject's disease shows evidence of intolerance to lenalidomide;
- Subject is exhibiting clinical signs of central nervous system (CNS) involvement of MM;
- Subjects with known moderate or severe persistent asthma within the past 5 years;
- Subject has active hepatitis B or C virus infection15. Subject is seropositive for human immunodeficiency virus (HIV);
- Subject has clinically significant cardiac disease;
- 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;
- Subject with known or suspicious conditions that would lead to failure to abide by the study protocol.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952091
Locations
Show 41 study locations
Sponsors and Collaborators
I-Mab Biopharma Co. Ltd.
| Responsible Party: | I-Mab Biopharma Co. Ltd. |
| ClinicalTrials.gov Identifier: | NCT03952091 |
| Other Study ID Numbers: |
TJ202001MMY301 |
| First Posted: | May 16, 2019 Key Record Dates |
| Last Update Posted: | October 18, 2022 |
| Last Verified: | October 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone |
Dexamethasone acetate Lenalidomide BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors |