Teclistamab for Smoldering Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Dana Farber Cancer Institute, Boston, MA
Smoldering Multiple Myeloma+5 More
Teclistamab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to test the anti-cancer activity of Teclistamab and to compare it with Lenalidomide + Dexamethasone combination in people with high risk smoldering multiple myeloma. People with smoldering multiple myeloma (SMM) usually do not have symptoms but are at risk for progressing to active multiple myeloma (MM). Multiple Myeloma is a cancer of the plasma cells, which are an important part of the immune system. Patients with active multiple myeloma generally require treatment but there are currently no approved therapies for smoldering multiple myeloma. The names of the study drugs involved in this study are: Teclistamab Lenalidomide (also called Revlimid) Dexamethasone (also called Decadron)

Eligible Conditions

  • Smoldering Multiple Myeloma
  • Smoldering myeloma
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Smoldering Multiple Myeloma

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Baseline through end of post-treatment follow up period, an average of 5 years

Day 28
To assess ability to collect stem cells after Teclistamab
Year 5
To assess incidence of Treatment-Emergent Adverse Events that are assessed by the number of patients experiencing at least one treatment-related grade 3 or higher AE of any type during the time of observation
Year 3
Minimal Residual Disease (MRD) Negativity
Day 28
Immunogenicity of Teclistamab in SMM
Week 8
Pharmacodynamic biomarkers of antimyeloma and immune activity of Teclistamab
Pharmacokinetics of teclistamab in SMM
Day 28
Complete Response Rate (CRR)
Year 5
Duration of Response (DOR)
Time to progression
Year 3
To assess Overall Survival (OS)
Year 3
Progression-free survival (PFS) until progression to myeloma
Progression-free survival (PFS-2) post initiation of overt myeloma therapy

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Smoldering Multiple Myeloma

Trial Design

2 Treatment Groups

Lenalidomide + Dexamethasone (LD)
1 of 2
Teclistamab
1 of 2
Active Control
Experimental Treatment

51 Total Participants · 2 Treatment Groups

Primary Treatment: Teclistamab · No Placebo Group · Phase 2

Teclistamab
Drug
Experimental Group · 1 Intervention: Teclistamab · Intervention Types: Drug
Lenalidomide + Dexamethasone (LD)ActiveComparator Group · 2 Interventions: Lenalidomide, Dexamethasone · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through end of post-treatment follow up period, an average of 5 years
Closest Location: Dana Farber Cancer Institute · Boston, MA
Photo of dana farber cancer institute 1Photo of dana farber cancer institute 2Photo of dana farber cancer institute 3
2004First Recorded Clinical Trial
9 TrialsResearching Smoldering Multiple Myeloma
542 CompletedClinical Trials

Who is running the clinical trial?

Janssen Research & Development, LLCIndustry Sponsor
916 Previous Clinical Trials
6,326,817 Total Patients Enrolled
4 Trials studying Smoldering Multiple Myeloma
628 Patients Enrolled for Smoldering Multiple Myeloma
Irene Ghobrial, MDLead Sponsor
Irene C Ghobrial, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
5,000 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
A diagnosis of IgG-only MGUS should be considered if the BMPCs are clonal and the uninvolved immunoglobulin isotype is reduced by ≥1.
The FLC ratio is greater than 10%, 25%, or 40%.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.