Description:
The purpose of this study is evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).
Clinical Trials /
A Study of Teclistamab, in Participants With Relapsed or Refractory Multiple Myeloma
NCT04557098
Related Conditions:
- Multiple Myeloma
Recruiting Status:
Recruiting
Phase:
Phase 2
Trial Eligibility
Document
Title
- Brief Title: A Study of Teclistamab, in Participants With Relapsed or Refractory Multiple Myeloma
- Official Title: A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma
Clinical Trial IDs
- ORG STUDY ID: CR108859
- SECONDARY ID: 2016-002122-36
- SECONDARY ID: TECLIMMY1001-P3
- NCT ID: NCT04557098
Conditions
- Hematological Malignancies
Interventions
| Drug | Synonyms | Arms |
|---|---|---|
| Teclistamab | JNJ-64007957 | Part 3: Teclistamab |
Purpose
The purpose of this study is evaluate the efficacy of teclistamab at the recommended Phase 2
dose (RP2D).
Detailed Description
Study record NCT03145181 is Phase 1 part of this study and study record NCT04557098 is Phase
2 part of this study.
Trial Arms
| Name | Type | Description | Interventions |
|---|---|---|---|
| Part 3: Teclistamab | Experimental | Participants in all cohorts will receive teclistamab SC at an RP2D. |
|
Eligibility Criteria
Inclusion 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: Multiple myeloma must be measurable by central laboratory
assessment
- Women 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
- Cohort 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)
Exclusion Criteria:
- Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary
amyloid light-chain amyloidosis
- 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
- Prior autologous stem cell transplant <=12 weeks
- Live, attenuated vaccine within 4 weeks prior to the first dose of teclistamab
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Overall Response Rate (ORR) |
| Time Frame: | Up to 2.9 years |
| Safety Issue: | |
| Description: | ORR is defined as the proportion of participants who have a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria. |
Secondary Outcome Measures
| Measure: | Duration of Response (DOR) |
| Time Frame: | Up to 2.9 years |
| Safety Issue: | |
| Description: | DOR will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria, or death due to PD, whichever occurs first. |
| Measure: | Very Good Partial Response (VGPR) or Better Rate |
| Time Frame: | Up to 2.9 years |
| Safety Issue: | |
| Description: | VGPR or better rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria. |
| Measure: | Complete Response (CR) or Better Rate |
| Time Frame: | Up to 2.9 years |
| Safety Issue: | |
| Description: | CR or better rate is defined as the percentage of patients who achieve a complete response (CR) or better according to IMWG response criteria. |
| Measure: | Stringent Complete Response (sCR) Rate |
| Time Frame: | Up to 2.9 years |
| Safety Issue: | |
| Description: | sCR rate is defined as the percentage of patients who achieve a stringent complete response (sCR) according to IMWG response criteria. |
| Measure: | Time to Response (TTR) |
| Time Frame: | Up to 2.9 years |
| Safety Issue: | |
| Description: | TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better. |
| Measure: | Progression-free Survival (PFS) |
| Time Frame: | Up to 2.9 years |
| Safety Issue: | |
| Description: | PFS is defined as the time from the date of first dose of study drug to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first. |
| Measure: | Overall Survival (OS) |
| Time Frame: | Up to 2.9 years |
| Safety Issue: | |
| Description: | OS is defined as the time from the date of first dose of study drug to the date of the participant's death. |
| Measure: | Minimal Residual Disease (MRD) Negative Rate |
| Time Frame: | Up to 2.9 years |
| Safety Issue: | |
| Description: | MRD-negative rate is defined as the proportion of participants who achieved MRD-negative status to a threshold of 10^-5 at any timepoint after initial dose of teclistamab and before disease progression or starting subsequent therapy |
| Measure: | Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability |
| Time Frame: | Up to 2.9 years |
| Safety Issue: | |
| Description: | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. |
| Measure: | Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability |
| Time Frame: | Up to 2.9 years |
| Safety Issue: | |
| Description: | An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. |
| Measure: | Number of Participants with AEs by Severity |
| Time Frame: | Up to 2.9 years |
| Safety Issue: | |
| Description: | Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event. |
| Measure: | Number of Participants with Laboratory Abnormalities in Clinical Laboratory Values |
| Time Frame: | Up to 2.9 years |
| Safety Issue: | |
| Description: | Number of participants with laboratory abnormalities in clinical laboratory values (such as hemoglobin, platelets) will be reported. |
| Measure: | Serum Concentration of Teclistamab |
| Time Frame: | Up to 3 months |
| Safety Issue: | |
| Description: | Serum concentrations of teclistamab will be reported. |
| Measure: | Number of Participants with Teclistamab Antibodies |
| Time Frame: | Up to 2.9 years |
| Safety Issue: | |
| Description: | Antibodies to teclistamab will be assessed to evaluate potential immunogenicity. |
| Measure: | Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30) |
| Time Frame: | Baseline, up to 2.9 years |
| Safety Issue: | |
| Description: | The EORTC- QLQ-Core-30 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The recall period is 1 week ("past week") and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms. |
| Measure: | Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L) |
| Time Frame: | Baseline, up to 2.9 years |
| Safety Issue: | |
| Description: | The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 separate questions are categorical and cannot be analyzed as cardinal numbers. |
| Measure: | Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS) |
| Time Frame: | Baseline, up to 2.9 years |
| Safety Issue: | |
| Description: | The PGIS is a single item that assesses severity of the participant's health state, on a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe). |
| Measure: | Overall Response Rate (ORR) in Participants with High-risk Molecular Features |
| Time Frame: | Up to 2.9 years |
| Safety Issue: | |
| Description: | ORR in participants with high risk is defined as the overall response rate among the high risk molecular subgroups (del17p, t(4;14), t(14;16), or other high-risk molecular subtypes). |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Janssen Research & Development, LLC |
Last Updated
August 17, 2021
