Treatment (combination chemotherapy) for Plasma Cell Myeloma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mayo Clinic in Rochester, Rochester, MN
Plasma Cell Myeloma+3 More
Carfilzomib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase II trial test whether combination chemotherapy works to improve blood test results in patients with high-risk multiple myeloma. Chemotherapy drugs, such as carfilzomib, daratumumab, lenalidomide, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help determine if patients who have a small amount of cancer left after the initial treatment, called minimal residual disease, will benefit from the drug combination.

Eligible Conditions

  • Plasma Cell Myeloma
  • ISS Stage III Plasma Cell Myeloma

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: From registration to death due to any cause, assessed up to 10 years

At 1 year
Rate of sustained minimal residual disease (MRD) negativity
Month 24
Bone marrow microenvironment
Clonal architecture before treatment
Day 28
Overall response rate (>= confirmed very good partial response ([VGPR])
Year 10
Overall survival
Year 10
Progression-free survival
Day 30
Incidence of adverse events

Trial Safety

Safety Progress

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

Trial Design

1 Treatment Group

Treatment (combination chemotherapy)
1 of 1
Experimental Treatment

75 Total Participants · 1 Treatment Group

Primary Treatment: Treatment (combination chemotherapy) · No Placebo Group · Phase 2

Treatment (combination chemotherapy)Experimental Group · 8 Interventions: Carfilzomib, Computed Tomography, Dexamethasone, Lenalidomide, Daratumumab, Bone Marrow Aspiration and Biopsy, Positron Emission Tomography, Magnetic Resonance Imaging · Intervention Types: Drug, Procedure, Drug, Drug, Biological, Procedure, Procedure, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
2014
Completed Phase 3
~1400
Computed Tomography
2017
Completed Phase 2
~3460
Dexamethasone
2007
Completed Phase 4
~2420
Lenalidomide
2005
Completed Phase 3
~1590
Daratumumab
2016
Completed Phase 4
~1400
Positron Emission Tomography
2019
Completed Phase 2
~3050
Magnetic Resonance Imaging
2017
Completed Phase 2
~1120

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from registration to death due to any cause, assessed up to 10 years
Closest Location: Mayo Clinic in Rochester · Rochester, MN
Photo of Rochester  1Photo of Rochester  2Photo of Rochester  3
2021First Recorded Clinical Trial
10 TrialsResearching Plasma Cell Myeloma
502 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have given informed written consent.
You are willing to return to the institution for follow-up during the active treatment phase of the trial.
You are willing to donate blood and bone marrow samples for planned research.
You must be older than 6 months.\n
You are able to take aspirin (325 mg) daily as prophylactic anticoagulation.
You have a suspected or confirmed newly diagnosed multiple myeloma.

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.