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Corticosteroid

Teclistamab vs Lenalidomide + Dexamethasone for Multiple Myeloma

Phase 2

Recruiting

Led By Irene C Ghobrial, MD

Research Sponsored by Irene Ghobrial, MD

Eligibility Criteria Checklist

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

Must have

Mandatory registration into the Revlimid REMS® program for participants randomized to lenalidomide

Age ≥18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through end of post-treatment follow up period, an average of 5 years

Awards & highlights

Study Summary

This trial will compare the anti-cancer activity of Teclistamab given as an infusion, with Lenalidomide + Dexamethasone given orally (by mouth).

Who is the study for?

This trial is for adults over 18 with high-risk smoldering multiple myeloma, which is a pre-cancerous stage of plasma cell cancer without symptoms. Participants must have certain blood and bone marrow conditions, be able to perform daily activities (ECOG 0-2), and not have had previous SMM treatments in the last 6 months. Women who can bear children must follow strict pregnancy prevention measures.Check my eligibility

What is being tested?

The study tests Teclistamab's effectiveness against a combination of Lenalidomide and Dexamethasone in patients with high-risk smoldering multiple myeloma. It aims to find out if early treatment can prevent progression to active multiple myeloma.See study design

What are the potential side effects?

Possible side effects include immune system reactions, infections due to low white blood cell counts, fatigue, digestive issues from Dexamethasone or Lenalidomide, and potential infusion-related reactions from Teclistamab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am registered in the Revlimid REMS program.

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I am 18 years old or older.

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I do not show signs of active multiple myeloma.

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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through end of post-treatment follow up period, an average of 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through end of post-treatment follow up period, an average of 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through end of post-treatment follow up period, an average of 5 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

Complete Response Rate (CRR)

Secondary outcome measures

Duration of Response (DOR)

Immunogenicity of Teclistamab in SMM

Minimal Residual Disease (MRD) Negativity

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TeclistamabExperimental Treatment1 Intervention

Each study treatment cycle lasts 28 days. Participants will be randomized into either Teclistamab arm or Lenalidomine + Dexamethoasone arm - Teclistamab-Per Protocol

Group II: Lenalidomide + Dexamethasone (LD)Active Control2 Interventions

Each study treatment cycle lasts 28 days. Participants will be randomized into either Teclistamab arm or Lenalidomine + Dexamethoasone arm Lenalidomine Dexamethoasone

0 / 4Eligibility criteria met

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Who is running the clinical trial?

Irene Ghobrial, MDLead Sponsor

Janssen Research & Development, LLCIndustry Sponsor

975 Previous Clinical Trials

6,384,301 Total Patients Enrolled

70 Trials studying Multiple Myeloma

19,410 Patients Enrolled for Multiple Myeloma

Irene C Ghobrial, MDPrincipal InvestigatorDana-Farber Cancer Institute

1 Previous Clinical Trials

5,000 Total Patients Enrolled

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05469893 — Phase 2

Multiple Myeloma Research Study Groups: Lenalidomide + Dexamethasone (LD), Teclistamab

Multiple Myeloma Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT05469893 — Phase 2

Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05469893 — Phase 2

Frequently Asked Questions

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

How secure is Teclistamab in the treatment of patients?

"Teclistamab's safety profile is judged to be a 2 on the 1-3 scale, as it has been studied in Phase 2 clinical trials which have shown promising results but do not indicate efficacy."

Answered by AI

How many participants are currently engaging in this research endeavor?

"Affirmative. According to clinicaltrials.gov, the recruitment process for this medical trial is currently underway, with data first posted on August 10th 2022 and most recently updated a day later. The study requires 51 participants from one site."

Answered by AI

Is recruitment still active for this medical research?

"Affirmative. The records hosted on clinicaltrials.gov demonstrate that this research trial launched on August 10th 2022 is actively enrolling participants. Specifically, 51 individuals must be recruited from a single centre for the study to proceed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Immuno-PRISM (PRecision Intervention Smoldering Myeloma)

Irene Ghobrial, MD 2022. "Immuno-PRISM (PRecision Intervention Smoldering Myeloma)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05469893.