A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT06425991
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Teclistamab — DRUG
    Teclistamab will be administered subcutaneously.

Study Details

The purpose of this study is to compare the pharmacokinetics (processes by which drugs are absorbed, distributed in the body, and excreted) between teclistamab made from the current commercial manufacturing process (pre-change) and the new manufacturing process (post-change).

Key Dates

First listed
May 23, 2024
Start date
Jun 7, 2024
Status verified
Jul 2026
Primary completion
Jun 3, 2025
Completion
Mar 3, 2027

Study Design

Enrollment
108 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Pre-change Teclistamab
    Participants will receive teclistamab monotherapy (made from the pre-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first. Following completion of the planned analysis per protocol, approval of Amendment 3, and upon sponsor notification, participants from treatment phase will be transitioned to Drug Access Long-term Extension (DA-LTE) phase and will continue to receive the study treatment until they have either discontinued, withdrawn, or transitioned to one of the criteria specified in the protocol. Based on primary analysis demonstrating comparability between pre- and post-change teclistamab, flexibility has been introduced to allow participants to switch from their current teclistamab treatment, if necessary.
  • Experimental: Arm B: Post-change Teclistamab
    Participants will receive teclistamab monotherapy (made from the post-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first. Following completion of the planned analysis per protocol, approval of Amendment 3, and upon sponsor notification, participants from treatment phase will be transitioned to DA-LTE phase to receive the study treatment until they have either discontinued, withdrawn, or transitioned to one of the criteria specified in the protocol. Based on primary analysis demonstrating comparability between pre- and post-change teclistamab, flexibility has been introduced to allow participants to switch from their current teclistamab treatment, if necessary.

Primary Outcome Measure

Maximum Observed Serum Concentration (Cmax) of First Treatment Dose of Teclistamab [ Time Frame: Cycle 1 (28 days cycle): Predose to Day 7 postdose ]

Locations (7)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
Colorado Blood Cancer InstituteDenverColorado80218-
Cleveland Clinic FloridaWestonFlorida33331-
Augusta University- Georgia Cancer CenterAugustaGeorgia30912-
St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Franciscan HealthIndianapolisIndiana46237-
Cleveland ClinicClevelandOhio44195-
Baylor University Medical CenterDallasTexas75246-

Find similar trials in Gilbert, AZ

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Banner MD Anderson Cancer Center· Gilbert, AZColorado Blood Cancer Institute· Denver, COCleveland Clinic Florida· Weston, FLAugusta University- Georgia Cancer Center· Augusta, GASt Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Franciscan Health· Indianapolis, INCleveland Clinic· Cleveland, OH

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