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CAR T-cell Therapy

Dose Escalation Cohort: Dose Level (DL) 1 (Talquetamab, Iberdomide, Dexamethasone) for Multiple Myeloma

Q: What is the safety profile of Dose Escalation Cohort: Dose Level (DL) 1 that includes Talquetamab, Iberdomide, and Dexamethasone for individuals?

<p>Based on our assessment at Power, the safety rating for Dose Escalation Cohort: Dose Level (DL) 1 comprising Talquetamab, Iberdomide, and Dexamethasone is designated as 1. This score reflects it being a Phase 1 trial with restricted evidence validating both safety and efficacy.</p>

Phase 1

Waitlist Available

Research Sponsored by Thomas Martin, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of using a combination of talquetamab, iberdomide, and dexamethasone to treat patients with multiple myeloma that has come

Who is the study for?

This trial is for patients with multiple myeloma that has returned (relapsed) or hasn't improved with treatment (refractory). Participants should have previously tried and not responded well to certain other treatments, including BCMA targeted therapy.Check my eligibility

What is being tested?

The trial tests a combination of talquetamab, iberdomide, and dexamethasone for safety and effectiveness. Talquetamab is FDA-approved alone but is being studied here with the investigational drug iberdomide and the corticosteroid dexamethasone.See study design

What are the potential side effects?

Potential side effects may include immune system reactions, inflammation in various organs due to talquetamab's action on T-cells, possible protein targeting effects from iberdomide, and typical steroid-related issues from dexamethasone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate (ORR) (Dose Expansion Cohort)

Proportion of participants experiencing Dose-Limiting Toxicity (DLTs) (Dose Escalation Cohorts)

Proportion of participants experiencing Dose-Limiting Toxicity (DLTs) (Dose Expansion Cohort)

+2 more

Secondary outcome measures

Changes in scores on the EORTC QLQ- Multiple Myeloma Questionnaire (EORTC-QLQ-M20) over time

Changes in scores on the European Organization for Research and Treatment of Cancer - Quality of Life questionnaire (EORTC-QLQ-C30) over time

Number of participants achieving VGPR or CR and MRD (negative (-)) response

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose Expansion Cohort (Talquetamab, Iberdomide, Dexamethasone)Experimental Treatment4 Interventions

Participants receive the recommended phase 2 dose of Talquetamab and Iberdomide, and 20-40mg of Dexamethasone which may be continued at the discretion of the investigator. Treatment repeats every 35 days for cycle 1 and then every 28 days for subsequent cycles in the absence of disease progression or unacceptable toxicity. Participants also undergo bone marrow biopsy, imaging scans, tissue and blood sample collection throughout the study.

Group II: Dose Escalation Cohort: Dose Level (DL) 1 (Talquetamab, Iberdomide, Dexamethasone)Experimental Treatment4 Interventions

Participants receive 0.8mg/kg of Talquetamab over 1-3 minutes on days 1, 4, 8, and 15 of cycle 1, days 1 and 15 of cycles 2-6, day 1 of cycle 7 and subsequent cycles, 0.75mg Iberdomide once a day on days -7 thru day 14 of cycle 1, days 1-21 of cycle 2 and subsequent cycles, and 20-40mg of Dexamethasone on days 1, 4, 8, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycles 2-4, and may be continued at the discretion of the investigator. Treatment repeats every 35 days for cycle 1 and then every 28 days for subsequent cycles in the absence of disease progression or unacceptable toxicity. Participants also undergo bone marrow biopsy, imaging scans, tissue and blood sample collection throughout the study.

Group III: Dose Escalation Cohort: DL 3 (Talquetamab, Iberdomide, Dexamethasone)Experimental Treatment4 Interventions

Participants receive 0.8mg/kg of Talquetamab over 1-3 minutes on days 1, 4, 8, and 15 of cycle 1, days 1 and 15 of cycles 2-6, day 1 of cycle 7 and subsequent cycles, 1.3 mg Iberdomide once a day on days -7 thru day 14 of cycle 1, days 1-21 of cycle 2 and subsequent cycles, and 20-40mg of Dexamethasone on days 1, 4, 8, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycles 2-4, and may be continued at the discretion of the investigator. Treatment repeats every 35 days for cycle 1 and then every 28 days for subsequent cycles in the absence of disease progression or unacceptable toxicity. Participants also undergo bone marrow biopsy, imaging scans, tissue and blood sample collection throughout the study.

Group IV: Dose Escalation Cohort: DL 2 (Talquetamab, Iberdomide, Dexamethasone)Experimental Treatment4 Interventions

Participants receive 0.8mg/kg of Talquetamab over 1-3 minutes on days 1, 4, 8, and 15 of cycle 1, days 1 and 15 of cycles 2-6, day 1 of cycle 7 and subsequent cycles, 1.0mg Iberdomide once a day on days -7 thru day 14 of cycle 1, days 1-21 of cycle 2 and subsequent cycles, and 20-40mg of Dexamethasone on days 1, 4, 8, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycles 2-4, and may be continued at the discretion of the investigator. Treatment repeats every 35 days for cycle 1 and then every 28 days for subsequent cycles in the absence of disease progression or unacceptable toxicity. Participants also undergo bone marrow biopsy, imaging scans, tissue and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Iberdomide

2021

Completed Phase 1

~60

Dexamethasone

2007

Completed Phase 4

~2590

Bone Marrow Biopsy

2021

Completed Phase 2

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Thomas Martin, MDLead Sponsor

3 Previous Clinical Trials

107 Total Patients Enrolled

3 Trials studying Multiple Myeloma

107 Patients Enrolled for Multiple Myeloma

Janssen Research & Development, LLCIndustry Sponsor

975 Previous Clinical Trials

6,384,270 Total Patients Enrolled

70 Trials studying Multiple Myeloma

19,379 Patients Enrolled for Multiple Myeloma

Bristol-Myers SquibbIndustry Sponsor

2,639 Previous Clinical Trials

4,128,994 Total Patients Enrolled

87 Trials studying Multiple Myeloma

29,882 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment phase for this medical study currently ongoing?

"Per the details on clinicaltrials.gov, recruitment for this specific trial has concluded. Although it was initially registered on July 1st, 2024 and last modified on March 29th, 2024, there are currently no active efforts to enroll participants. However, it is important to note that out of a total of 812 ongoing trials listed, other studies are actively seeking candidates at present."

Answered by AI

What are the principal goals that this medical study aims to achieve?

"The primary objective of this extended-duration clinical trial, spanning up to 3 years, is to evaluate the percentage of participants reporting treatment-related adverse events in the Dose Escalation Cohorts. Secondary goals include assessing the number of participants achieving VGPR or CR and MRD (-) response using stringent criteria: attaining ≥ VGPR and <1 multiple myeloma clone per 100,000 bone marrow cells (10-5) as measured by next-generation sequencing (NGS). Additionally, further secondary objectives comprise analyzing treatment-linked adverse events such as toxicity assessed through CTCAE version 5.0; evaluating cytokine release syndrome"

Answered by AI

What is the safety profile of Dose Escalation Cohort: Dose Level (DL) 1 that includes Talquetamab, Iberdomide, and Dexamethasone for individuals?

"Based on our assessment at Power, the safety rating for Dose Escalation Cohort: Dose Level (DL) 1 comprising Talquetamab, Iberdomide, and Dexamethasone is designated as 1. This score reflects it being a Phase 1 trial with restricted evidence validating both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma

Thomas Martin, MD 2024. "Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06348108.