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Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd) for Relapsed or Refractory Multiple Myeloma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University of Connecticut, Farmington, CTRelapsed or Refractory Multiple MyelomaBortezomib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will compare the effectiveness of two different cancer treatments.

Eligible Conditions
  • Relapsed or Refractory Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
CART-ddBCMA
1
PD-1 Inhibitor
1
UCARTCS1A

Study Objectives

1 Primary · 20 Secondary · Reporting Duration: Up to 9 years

Month 6
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Year 9
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score
Change from Baseline in Symptoms, Functioning, and Overall Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)
Up to 9 years
Complete Response (CR) or Better Response
Depth of Response in Participants in High-risk Molecular Features
Duration of Response (DOR)
Minimal Residual Disease (MRD) Negativity
Number of Participants with Abnormal Laboratory Results
Number of Participants with Adverse Events (AEs) by Severity
Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab
Number of Participants with Serious Adverse Events (SAEs) by Severity
Overall Response (Partial Response [PR] or Better)
Overall Survival (OS)
PFS in Participants in High-risk Molecular Features
Progression-free Survival (PFS)
Therapeutic procedure
Serum Concentrations of Teclistamab
Therapeutic procedure
Time to Worsening in Symptoms, Functioning, and Overall HRQoL
Very Good Partial Response (VGPR) or Better Response

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
CART-ddBCMA
1
PD-1 Inhibitor
1
UCARTCS1A

Trial Design

2 Treatment Groups

Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethason...
1 of 2
Teclistamab
1 of 2

Experimental Treatment

590 Total Participants · 2 Treatment Groups

Primary Treatment: Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd) · No Placebo Group · Phase 3

Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd)Experimental Group · 4 Interventions: Bortezomib, Dexamethasone, Pomalidomide, Carfilzomib · Intervention Types: Drug, Drug, Drug, Drug
Teclistamab
Drug
Experimental Group · 1 Intervention: Teclistamab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bortezomib
2005
Completed Phase 2
~1250
Dexamethasone
2007
Completed Phase 4
~2420
Pomalidomide
2011
Completed Phase 2
~1330
Carfilzomib
2014
Completed Phase 3
~1400

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 9 years

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
933 Previous Clinical Trials
6,368,141 Total Patients Enrolled
5 Trials studying Relapsed or Refractory Multiple Myeloma
900 Patients Enrolled for Relapsed or Refractory Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
716 Previous Clinical Trials
3,950,282 Total Patients Enrolled
5 Trials studying Relapsed or Refractory Multiple Myeloma
900 Patients Enrolled for Relapsed or Refractory Multiple Myeloma

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Are enrollees still being accepted for this research study?

"No, this particular study is not recruiting new patients at the moment. Although, it should be noted that the trial was last updated on November 3rd, 2022 and there are 826 other trials with active recruitment drives." - Anonymous Online Contributor

Unverified Answer

Is this study widely available in Canada?

"Including but not limited to, Virginia Commonwealth University - Massey Cancer Center in Richmond, Tom Baker Cancer Centre in Calgary, and Juravinski Cancer Centre in Hamilton; there are 7 medical centres currently running this study." - Anonymous Online Contributor

Unverified Answer

Could you please explain the potential risks associated with taking Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd)?

"Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd) have both undergone multiple rounds of testing to prove their safety, so they received a score of 3." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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