Isatuximab and Standard Procedures for Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Columbia University, New York, NY
Lymphoma+6 More
Isatuximab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to see if Isatuximab can alter the immune system in patients with multiple myeloma or lymphoma upon recovery from the autologous stem cell transplantation. The investigators will see if Isatuximab makes changes to the immune system so that upon recovery from the transplant, the immune system can fight the cancer. This study will have two arms. On one arm (control arm), participants will receive standard transplant procedures and on the other arm (experimental arm), participants will receive Isatuximab in addition to the standard transplant procedures. The assignment to these arms is done randomly (determined by chance, like flipping a coin) by a computer. Each participant will have about 66% chance of getting on the experimental arm and about 33% chance of getting on the control arm.

Eligible Conditions

  • Lymphoma
  • Multiple Myeloma
  • Non-Hodgkin's Lymphoma (NHL)
  • Relapsed Hodgkin's Disease, Adult

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 1 year

Day 30
Change in the total lymphocyte count
Percentage of participants with absolute lymphocyte count >500 cells/microliter
Up to 1 year
CD8 and CD4 Subsets
Number of Adverse Events
Percentage of Natural Killer (NK) cells
Percentage of activated B and T regulatory cells
Percentage of activated helper and effector T cells

Trial Safety

Safety Progress

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

Trial Design

2 Treatment Groups

Isatuximab and Standard Procedures
1 of 2
Standard procedures
1 of 2
Experimental Treatment

39 Total Participants · 2 Treatment Groups

Primary Treatment: Isatuximab and Standard Procedures · No Placebo Group · Phase 2

Isatuximab and Standard Procedures
Drug
Experimental Group · 1 Intervention: Isatuximab · Intervention Types: Drug
Standard procedures
Other
Experimental Group · 1 Intervention: Standard Procedures · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isatuximab
2015
Completed Phase 1
~60

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year
Closest Location: Columbia University · New York, NY
Photo of Columbia University  1Photo of Columbia University  2Photo of Columbia University  3
2006First Recorded Clinical Trial
4 TrialsResearching Lymphoma
409 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
A peripheral T-cell lymphoma that has been treated with first-line therapy or at relapse.
A) Consolidation after first line induction therapy or at first relapse.
You have relapsed Hodgkin's disease or non-Hodgkin's lymphoma.
You have had a previous indolent or transformed indolent B cell lymphoma and you have received second line therapy.
Any prior therapy for the malignancy is allowed.

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.