Overview

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

Status:
Active, not recruiting
Trial end date:
2022-07-31
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
I-Mab Biopharma Co. Ltd.
I-Mab Biopharma HongKong Limited
Treatments:
BB 1101
Dexamethasone
Dexamethasone acetate
Lenalidomide
Criteria
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.