An Open label Study of Teclistamab in Subjects with Relapsed or Refractory Multiple Myeloma
- Conditions
- Relapsed or Refractory Multiple MyelomaMedDRA version: 20.0Level: HLGTClassification code 10005330Term: Blood and lymphatic system disorders congenitalSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-002122-36-IT
- Lead Sponsor
- JANSSEN CILAG INTERNATIONAL NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 228
1. >=18 years of age.
2. Documented diagnosis of MM according to IMWG diagnostic criteria.
3. Part 1 and Part 2
Measurable MM that is relapsed or refractory to established therapies with known clinical benefit in relapsed/refractory MM or be intolerant of those established MM therapies, and a candidate for teclistamab treatment in the opinion of the treating physician. Prior lines of therapy must include a PI, an IMiD and an anti-CD38 monoclonal antibody in any order during the course of treatment. Subjects who could not tolerate a PI, IMiD, or an anti-CD38 monoclonal antibody are allowed. In Part 2 (dose expansion), in addition to above criteria, MM must be measurable central lab assessment is not available, relevant local lab measurement must exceed the minimum required level by at least 25%.
Part 3
Measurable disease
Cohort A, B,C: MM must be measurable by central lab assessment:
• Serum monoclonal paraprotein (M-protein) level =1.0 g/dL or urine Mprotein level =200 mg/24 hours; or
• Light chain MM without measurable disease in the serum or the urine:
Serum immunoglobulin free light chain (FLC) =10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio. If central lab assessments are not available, relevant local lab measurements must exceed the min required level by at least 25%.
Prior treatment:
• Cohort A: Subjects must have 1) received >=3 prior lines of therapy or be double refractory to a PI and IMiD and 2) previously received a PI, an IMiD, and an anti-CD38 monoclonal antibody
- Cohort B: received >=4 prior lines of therapy and whose disease is penta-drug refractory to an anti-CD38 monoclonal antibody, =2 PIs, =2 IMiDs (refractory multiple myeloma as defined by IMWG consensus criteria).
- Cohort C: received >=3 prior lines of therapy that included a PI, an IMiD, an anti-CD38 monoclonal antibody, and an anti-BCMA treatment (with CAR-T cells or an ADC).
For full inclusion criteria, refer to section 4.1 inclusion criteria of the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 182
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46
1. Prior treatment with any BCMA-targeted therapy with the exception of Cohort C in Part 3.
2. Prior antitumor therapy as follows, before the first dose of study drug:
-Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less.
-Monoclonal antibody treatment for multiple myeloma within 21 days
-Cytotoxic therapy within 21 days
-Proteasome inhibitor therapy within 14 days
-Immunomodulatory agent therapy within 7 days
-Gene modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, natural killer [NK] cells) within 3 months
-Radiotherapy within 14 days or focal radiation within 7 days.
3. Toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.
4. Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within the 14-day period before the first dose of study drug. (does not include pretreatment medication)
5. Stem cell transplantation:
-An allogeneic stem cell transplant within 6 months. Subjects who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease.
-Received an autologous stem cell transplant <=12 weeks before the first dose of study drug.
6. Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
7. Plasma cell leukemia (>2.0 x 10 to the 9th/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome
(polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.
8. Known to be seropositive for human immunodeficiency virus or acquired immune deficiency syndrome
9. Hepatitis B infection or at risk for hepatitis B virus reactivation as defined according to the American Society of Clinical Oncology guidelines.2,22 Eligibility will be determined by the investigator as described in Attachment 14. In the event the infection status is unclear, quantitative levels are necessary to determine the
infection status (Attachment 14). Active Hepatitis C infection as measured by positive hepatitis C virus (HCV)-RNA testing. Subjects with a history of HCV antibody positivity must undergo HCV-RNA testing.
10. Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation.
11. Known allergies, hypersensitivity, or intolerance to excipients of the study drug (teclistamab) or its excipients.
For full exclusion criteria, refer to pg 117-121 of the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method