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Clinical Trials List

Protocol NumberTJ202001MMY301
NCT Number(ClinicalTrials.gov Identfier)NCT03952091

2019-01-01 - 2026-04-30

Phase III

Terminated5

ICD-10C90.02

Multiple myeloma in relapse

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

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

    I-Mab Biopharma Co. Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 戴明燊 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 王銘崇 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Chieh-Lin Teng Division of Hematology & Oncology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Shang-Yi Huang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Audit

None

Condition/Disease

Relapsed or Refractory Multiple Myeloma

Objectives

Primary Objectives• To compare efficacy of TJ202 when combined with lenalidomide and dexamethasone(TJ202+Rd) to that of lenalidomide and dexamethasone (Rd), in terms ofprogression-free survival (PFS) in subjects with relapsed or refractory multiplemyeloma who received at least 1 line of treatment.

Test Drug

TJ202

Active Ingredient

IgG 1 mAb

Dosage Form

injecion

Dosage

65

Endpoints

1.Primary Endpoint:
 Progression-free survival (PFS): defined as the duration from the date of randomization to
either PD, according to the IMWG criteria, or death, whichever occurs first.
2. Secondary Endpoints:
 Minimal residual disease (MRD) assessment: the proportion of MRD-negative in subjects
achieve CR or better;
 The proportion of subjects who achieve VGPR or better;
 Duration of response (DOR);
 Time to response (TTR);
 Time to progression (TTP);
 Overall response rate (ORR);
 Overall survival (OS);
 Adverse events (AEs);
 Vital signs, ECG, physical examination, ECOG performance status and laboratory
findings;
 Anti-TJ202 antibody and neutralizing antibody.
3. Other Endpoints
 Score for the assessment of self-reported quality of life (EQ-5D-5L)

Inclution Criteria

Main inclusion criteria:
1. Age ≥ 18, male or female;
* Age ≥ 20 for study sites in Taiwan according to local requirements
2. Subject must have had documented MM:
• Monoclonal plasma cells in the bone marrow ≥10% at some point in their disease
history, or presence of a biopsy-proven plasmacytoma;
3. At screening phase, subject must have one or more measurable disease as the following
measurements:
1) Serum M-protein level ≥0.5g/dL;
2) Urine M-protein level≥ 200 mg/24h;
3) Serum immunoglobulin free light chain ≥ 10 mg/dL and abnormal serum
immunoglobulin kappa lambda free light chain ratio;
4. Subject must have received at least 1 prior line of treatment for MM;
* "1 line of treatment" refers to initial treatment regimen; or the treatment regimen with
one or several drugs used during the period between the first time of PD and the second
times of PD. Radiotherapy, diphosphonate therapy or a short-term steroid treatment will
not be considered as a prior line of treatment.
5. Subject is in a state of progressive disease (PD);
6. Subject must have life expectancy of no less than 6 months;
7. Subject must have an ECOG (Eastern Cooperative Oncology Group) performance status
score of 0~2;
8. Subject has the following laboratory test results during the screening phase:
a) Hemoglobulin level ≥ 7 g/dL, without blood transfusion within 7 days before the
laboratory test;
b) Platelets count ≥ 50×109/L, without blood transfusion within 7 days before the
laboratory test;
c) Absolute neutrophil count (ANC) ≥1.0×109/L, use of granulocyte
colony-stimulating factor (G-CSF) is allowed;
d) ALT (aspartate aminotransferase) ≤ 2.5×ULN (upper limit of normal range); ALT
(alanine aminotransferase) ≤ 2.5×ULN;
e) Total bilirubin ≤ 1.5×ULN;
f) Estimated creatinine clearance ≥ 40 mL/min based on Cockcroft-Gault equation;
*Cockcroft-Gault equation: ([140 – Age] × Weight [kg] / [72 × Cc mg/dL]); ×0.85
(if female subject)
g) Corrected serum calcium ≤3.5mmol/L (14.0mg/dL) corrected based on albumin;
9. 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 first study agent administration; as well as those should avoid intercourse with
the opposite sex or should adopt two reliable methods of contraception at the same time
during the study period. Such reliable methods of contraception include a highly effective
method of contraception (tubal ligation, intrauterine device, hormones [contraceptives,
injections, hormone patches, pessary or implants], or vasoligation of the sexual partner)
and an additional effective method of contraception (male latex or synthetic condoms,
vaginal diaphragm or cervical cap). A woman of child-bearing potential 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;
10. 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 (e.g., condoms,
spermicidal foam, contraceptive gel, contraceptive diaphragm, contraceptive cream or suppository), 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;
11. 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;
12. Subject must be willing and able to adhere to the prohibitions and restrictions specified in
this protocol.

Exclusion Criteria

Main 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. Amyloidosis, plasma-cell leukemia (PL) (compliant with WHO criteria: presence of ≥
20% cells in peripheral blood, and an absolute count of plasma cell ≥ 2×109
/L), or
Waldenstrom Macroglobulinemia (WM) or POEMS syndrome;
5. Primary refractory multiple myeloma (subject failed to generate any minimal response or
any degree of response to any therapy);
6. Subject’s disease shows evidence of resistance to lenalidomide. If previously treated with
a lenalidomide-containing regimen, the subject is excluded if :
•Subject whose disease progresses within the period of receiving a
lenalidomide-containing regimen, or whose disease progresses within 60 days after the
last dose of lenalidomide (at least 2 cycles) previously;
∗ Subjects who received inadequate lenalidomide (less than 2 cycles) treatment is not
considered as resistant to lenalidomide.
7. Subject’s disease shows evidence of intolerance to lenalidomide;
8. Subject has received anti-myeloma treatment (radiotherapy is excluded) within 4 weeks or
5 PK half-lives of the treatment, whichever longer, before the first study agent
administration. This includes subjects who have received a cumulative dose of
corticosteroid greater than or equal to the equivalence of 140 mg prednisone or a single
dose of corticosteroid greater than or at a daily dose greater than 20 mg for 4 consecutive
days (except short-term use of corticosteroids, for example, the treatment of
life-threatening anaphylaxis and other reactions);
9. A history of other malignant tumors than multiple myeloma within 3 years prior to first
dosing (except malignancies that have been cured and have an extremely low risk of
relapse within 3 years as agreed by the investigator and the sponsor's medical monitor,
such as cutaneous squamous cell carcinoma and basal cell carcinoma, cervical cancer or
breast carcinoma);
10. Subject is exhibiting clinical signs of central nervous system (CNS) involvement of MM;
11. Subject has received plasma exchange within 28 days before first study agent
administration;
12. Subject with known chronic obstructive pulmonary disease (COPD) with a Forced
Expiratory Volume in 1 second (FEV1) <60% of predicted normal. Note that FEV1 testing is required for patients suspected of having COPD and subjects must be excluded if FEV1
<60% of predicted;
13. Subjects with known moderate or severe persistent asthma within the past 5 years
(National Heart, Lung, and Blood Institute (NHLBI) table of asthma severity), or
uncontrolled asthma of any classification;
14. Subject has active hepatitis B or C virus infection, and hepatitis serology needs to be
performed at screening phase:
•If tested positive for hepatitis B surface antigen (HBsAg), the subject should be
excluded. If tested positive for hepatitis B core antibody (HBcAb), with HBV-DNA 500
cps/ml prior to enrollment, the subject should be excluded;
•If a subject is positive for hepatitis C antibody test, a RNA CRP is needed and if his/her
test results prior to enrollment are confirmed positive, he/she should be excluded;
15. Subject is seropositive for human immunodeficiency virus (HIV);
16. Subject has clinically significant cardiac disease, including:
•Myocardial infarction within 6 months before the first study agent administration, or
unstable or uncontrolled disease/condition related to or affecting cardiac function, such
as unstable angina, congestive heart failure, New York Heart Association Class III-IV;
•Clinically significant ECG abnormalities, or uncontrolled cardiac arrhythmia;
•Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia’s
formula (QTc) >450 msec
17. 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;
18. Full recovery from the disease after previous treatment, with all side effects having
decreased to Grade 1 or below as assessed per NCI-CTCAE V5.0 (National Cancer
Institute Common Terminology Criteria for Adverse Events);
19. Subject has received an injection of live vaccine or attenuated vaccine within 4 weeks
before study agent administration;
20. Subject has received an investigational drug (including investigational vaccines) or used
an invasive investigational medical device within 4 weeks before the planned first dose of
study drug;
21. Subject has had major surgery (e.g., requiring general anesthesia) within 2 weeks before
first study grug administration, or are in the postoperative recovery, which, according to
the investigator’s judgment will affect this trial, or plan to undergo a scheduled surgery
during the trial period (subjects who have planned to undergo an operation under local
anesthesia can participate in this study);
22. Subject with known or suspicious conditions that would lead to failure to abide by the
study protocol, e.g., alcoholism, drug dependence or mental disorder, or presence of any
medical complications, or mental conditions or disorders (e.g., active systemic infection,
uncontrolled diabetes, acute diffuse infiltrative lung disease) that may cause interference
to study procedures or results, or possible risks to the subject arising from participation in
this study in the investigator's opinion; or presence of symptoms due to which the
investigator judges that, participating in this study is not the best choice (e.g., impairment
to the subject's health), or will affect, restrict or confound the evaluation of the study
protocol.

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    291 participants

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