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

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 orrefractor 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 statusscore 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 urinepregnancy test on the day of the first study agent administration; as well as thoseshould avoid sexual intercourse with the opposite sex or should adopt two reliablemethods of contraception at the same time during the study period. A woman ofchild-bearing potential is required to take effective contraceptive measuresthroughout this study and within 6 months after the last dosing; female subjectsmust agree not to donate any eggs for the purpose of assisted reproductionthroughout 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 havenot undergone vasoligation must agree to use barrier methods of birth control, orthat their partners use block caps (cervical cap or dome cap), spermicidal foam,contraceptive gel, contraceptive diaphragm, contraceptive cream, or suppository, andall 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 sheunderstands the purpose of, and procedures required for, the study and is willing toparticipate in the study;

11. Subject must be willing and able to adhere to the prohibitions and restrictionsspecified 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 hasreceived autologous stem cell transplant within 3 months before administration ofthe 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 ofMM;

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 forhuman 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 orknown sensitivity to mammalian-derived products;

12. Subject with known or suspicious conditions that would lead to failure to abide bythe study protocol.