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

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ClinicalTrials.gov Identifier: NCT03952091
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
I-Mab Biopharma HongKong Limited

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 31, 2022
Estimated Study Completion Date : July 31, 2022


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 :
  1. 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:

  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.

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


Contacts
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Contact: Ming Wu, Master 021-60578032 stefny.wu@i-mabbiopharma.com

Locations
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Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan
Contact: Tzeon-Jye Chiou, Doctor         
Sponsors and Collaborators
I-Mab Biopharma HongKong Limited

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Responsible Party: I-Mab Biopharma HongKong Limited
ClinicalTrials.gov Identifier: NCT03952091     History of Changes
Other Study ID Numbers: TJ202001MMY301
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: April 2019

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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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Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Multiple Myeloma
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