Isatuximab (for run-in portion) for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Multiple MyelomaIsatuximab (for run-in portion) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new treatment for multiple myeloma that has relapsed or become refractory to other treatments. It consists of three phases: screening, treatment, and follow-up.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Year 3

Year 3
Disease

Trial Safety

Safety Progress

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

Trial Design

2 Treatment Groups

Expansion
1 of 2
Safety Run-in
1 of 2

Experimental Treatment

53 Total Participants · 2 Treatment Groups

Primary Treatment: Isatuximab (for run-in portion) · No Placebo Group · Phase 2

ExpansionExperimental Group · 4 Interventions: Pomalidomide, Isatuximab (for expansion), Elotuzumab, Dexamethasone · Intervention Types: Drug, Drug, Drug, Drug
Safety Run-inExperimental Group · 4 Interventions: Pomalidomide, Elotuzumab, Dexamethasone, Isatuximab (for run-in portion) · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomalidomide
FDA approved
Elotuzumab
FDA approved
Dexamethasone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: year 3

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
566 Previous Clinical Trials
1,154,065 Total Patients Enrolled
14 Trials studying Multiple Myeloma
1,196 Patients Enrolled for Multiple Myeloma
Binod Dhakal, MDPrincipal InvestigatorMedical College of Wisconsin
2 Previous Clinical Trials
41 Total Patients Enrolled
2 Trials studying Multiple Myeloma
41 Patients Enrolled for Multiple Myeloma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
This sentence is about multiple myeloma patients who have had at least 2 different therapies that included lenalidomide and a proteasome inhibitor
The patient has a serum M-protein level of ≥0.5 g/dL, a urine M-protein level of ≥200 mg/24 hours, or a light chain multiple myeloma without measurable disease in the urine
The Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 means that the person is fully active and able to carry out all usual activities.
Progestogen-only contraception can be taken orally, injected, or implanted and is associated with preventing ovulation.
Do not have your period for at least one year before the screening visit, OR Have had surgery to prevent having a period, OR Use oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception which inhibits ovulation.
As opposed to single-barrier methods, double-barrier methods involve the use of two different types of barrier contraception
Male sterilization is surgically performed to permanently prevent a man from fathering a child
Before any study-related procedure is performed, the participant must give voluntary consent.
Subjects who are male or female and at least 18 years old.
The insertion of an intrauterine device (IUD) or an intrauterine hormone-releasing system (IUS) into the uterus.