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Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma

ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSCRI Development Innovations, LLC

About this trial

This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be ≥18 years of age (or the higher legal age in the jurisdiction in which the study is taking place) at the time of informed consent

Has documented diagnosis of MM according to the IMWG diagnostic criteria (Rajkumar 2011).

Teclistamab or Talquetamab + Tocilizumab: has received 2 or more prior MM therapies including a PI, IMiD and CD38 antibody.

Teclistamab + Oral Dexamethasone: has received 1 or more prior MM therapies including a PI, IMiD and/or CD38 antibody.

Disqualifiers

Has a rapidly progressing disease per investigator assessment.

Has plasma cell leukemia (>2.0×10^9/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.

Has known active CNS involvement or exhibits clinical signs of meningeal involvement of MM.

Has risk factors for developing clinically significant TLS and requiring management with increased hydration, allopurinol, or rasburicase.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Teclistamab

    Drug

    Teclistamab will be administered subcutaneously at step-up doses on Day 1, Day 4 and Day 8, one week after first treatment dose and weekly thereafter. In participants who have a partial response (PR) or better after 6 months of therapy, dosing frequency may be reduced to every 2 weeks.

  • Talquetamab

    Drug

    Talquetamab will be administered subcutaneously at step-up doses on Day 1, Day 4, Day 8 and Day 15, one week after first treatment dose and every 2 weeks thereafter. In participants who have a very good partial response (VGPR) or better after Cycle 4, dosing frequency may be reduced to every 4 weeks

  • Tocilizumab

    Drug

    Tocilizumab will be administered as a pretreatment medication in advance of administration of the first step-up dose of teclistamab or talquetamab on Cycle 1 Day 1.

  • Oral Dexamethasone

    Drug

    Oral dexamethasone will be administered as a pretreatment medication every 12 hours in 3 doses (PM/AM/PM) following each step-up dose and the first full dose of teclistamab in Cycle 1. A total of 9 doses of oral dexamethasone will be administered.

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Teclistamab/TocilizumabExperimental treatment 2 interventions
Group B: Talquetamab/TocilizumabExperimental treatment 2 interventions
Group C: Teclistamab/Oral DexamethasoneExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of CRS of any grade during the first two cycles

Evaluate the overall incidence of CRS in the first 2 cycles after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.

Time frame
From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)

Secondary outcomes

1

Incidence of recurrent CRS of any grade

Evaluate the incidence of recurrent CRS either after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.

Time frame
From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)
2

Incidence of CRS of any grade

Evaluate the incidence of CRS after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.

Time frame
Up to 12 months of teclistamab or 6 months for talquetamab treatment
3

Incidence of recurrent CRS of any grade

Evaluate the incidence of recurrent CRS after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.

Time frame
Up to 12 months of teclistamab or 6 months for talquetamab treatment
4

Incidence of Grade ≥2 CRS

Evaluate the incidence of Grade ≥2 CRS based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for CRS (Grade 1 to 5 with grade 5 defined as the worse outcome-Death) in the first 2 cycles after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.

Time frame
From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SCRI Development Innovations, LLC

Lead sponsor

Johnson & Johnson

Collaborator

Source ClinicalTrials.gov
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