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An Open label Study of Teclistamab in Subjects with Relapsed and Refractory Multiple Myeloma
EU CTIS ID: 2023-503438-40-00
What this study is testing
Part 1 (dose escalation): To identify the proposed RP2D(s) and schedule assessed to be safe for teclistamab Part 2 (dose expansion): To characterize the safety and tolerability of teclistamab at the proposed RP2D(s) Part 3 (Phase 2): To evaluate the efficacy of teclistamab at the RP2D
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Documented diagnosis of multiple myeloma according to IMWG diagnostic criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Measurable disease: Cohort A and Cohort C: Multiple myeloma must be measurable by central laboratory assessment
- A female participant of childbearing potential must have a negative pregnancy test at screening
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol
- Cohorts A: received at least 3 prior MM treatment lines of therapy. Prior therapy must include an IMiD, PI, and anti-CD38 monoclonal antibody; Cohort C: received ≥ 3 prior lines of therapy that included a PI, an IMiD, an anti-CD38 monoclonal antibody, and an anti-B cell maturation antigen (BCMA) treatment (with CART-T cells or an antibody drug conjugate (ADC)
You likely can't join if
- Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light-chain amyloidosis
- Prior autologous stem cell transplant ≤ 12 weeks
- Live, attenuated vaccine within 4 weeks prior to the first dose of teclistamab
- The following medical conditions: Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency virus (HIV) infection, hepatitis B or C infection, stroke or seizure less than or equal to (≤) 6 m, autoimmune disease, uncontrolled systemic infection, cardiac conditions (Myocardial Infarction ≤ 6 m, stage III-IV congestive heart failure, etc)
- Received any therapy that is targeted to BCMA, with the exception of Cohort C in Part 3
- Prior antitumor therapy, within 21 days (PI or radiotherapy within 14 days, IMiDs within 7 days, Gene modified adoptive cell therapy within 3 months) prior to first dose of study drug
See the full eligibility criteria
- Documented diagnosis of multiple myeloma according to IMWG diagnostic criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Measurable disease: Cohort A and Cohort C: Multiple myeloma must be measurable by central laboratory assessment
- A female participant of childbearing potential must have a negative pregnancy test at screening
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol
- Cohorts A: received at least 3 prior MM treatment lines of therapy. Prior therapy must include an IMiD, PI, and anti-CD38 monoclonal antibody; Cohort C: received ≥ 3 prior lines of therapy that included a PI, an IMiD, an anti-CD38 monoclonal antibody, and an anti-B cell maturation antigen (BCMA) treatment (with CART-T cells or an antibody drug conjugate (ADC)
- Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light-chain amyloidosis
- Prior autologous stem cell transplant ≤ 12 weeks
- Live, attenuated vaccine within 4 weeks prior to the first dose of teclistamab
- The following medical conditions: Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency virus (HIV) infection, hepatitis B or C infection, stroke or seizure less than or equal to (≤) 6 m, autoimmune disease, uncontrolled systemic infection, cardiac conditions (Myocardial Infarction ≤ 6 m, stage III-IV congestive heart failure, etc)
- Received any therapy that is targeted to BCMA, with the exception of Cohort C in Part 3
- Prior antitumor therapy, within 21 days (PI or radiotherapy within 14 days, IMiDs within 7 days, Gene modified adoptive cell therapy within 3 months) prior to first dose of study drug
- Toxicities from previous anticancer therapies that have not resolved to baseline or to ≤ grade 1 (except for alopecia or peripheral neuropathy)
- 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)
- Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma (MM)
- Myelodysplastic syndrome or active malignancies other than relapsed/refractory multiple myeloma with exceptions are: 1) Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured 2) Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured. 3) Noninvasive cervical cancer treated within the last 24 months that is considered completely cured. 4) Localized prostate cancer (N0M0) 5) Breast cancer: Adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence. 6) Malignancy that is considered cured with minimal risk of recurrence
- Prior allogenic stem cell transplant ≤ 6 months
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
- Canada
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom; Canada; China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.