Clinical Trials /

A Study of Teclistamab, in Participants With Relapsed or Refractory Multiple Myeloma

NCT04557098

Description:

The purpose of this study is evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).

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

DrugSynonymsArms
TeclistamabJNJ-64007957Part 3: Teclistamab

Purpose

The purpose of this study is evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D) (Part 3).

Detailed Description

      The corresponding study (NCT03145181) is the Phase 1 part of the study and TECLIMMY1001- Part
      3 is the Phase 2 part of the study.
    

Trial Arms

NameTypeDescriptionInterventions
Part 3: TeclistamabExperimentalParticipants in all cohorts will receive teclistamab SC at an RP2D.
  • Teclistamab

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 or are double
             refractory to an immunomodulatory imide drug (IMiD) and protease inhibitor (PI) Prior
             therapy must include an IMiD, PI, and anti-CD38 monoclonal antibody; Cohort B:
             received at least 4 prior MM treatment lines of therapies and whose disease is
             penta-refractory to at least 2 PIs, at least 2 IMiDs, and an anti-CD38 monoclonal
             antibody; Cohort C: received treatment with chimeric antigen receptor (CAR)-T therapy
             directed against B cell maturation antigen (BCMA) or an antibody drug conjugate (ADC)

        Exclusion Criteria:

          -  Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary
             amyloid light-chain amyloidosis

          -  The following cardiac conditions: Pulmonary compromise requiring supplemental oxygen
             use to maintain adequate oxygenation, human immunodeficiency virus (HIV), hepatitis B
             or C, 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 day (PI or radiotherapy within 14 day, IMiDs
             within 7 day ) prior to first dose of study drug

          -  Received a cumulative dose of corticosteroids equivalent to >= 140 milligram (mg) of
             prednisone within the 14-day period before the first dose of study drug

          -  Toxicities from previous anticancer therapies that 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)

          -  Active malignancies with exceptions are: 1) Non-muscle invasive bladder cancer. 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

          -  Known active CNS involvement or exhibits clinical signs of meningeal involvement of MM
      
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, as measured in participants who achieve CR/sCR, is defined as the proportion of participants who achieve MRD negative status.
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:Not yet recruiting
Lead Sponsor:Janssen Research & Development, LLC

Last Updated

September 17, 2020