Study Details

Open

Phase 2 Study of Istatuximab Plus Pomalidomide and Dexamethasone for Elderly and Frail Patients with Relapsed or Refractory Multiple Myeloma

The purpose of this study is to test the safety and effectiveness of a combination of treatments (isatuximab, pomalidomide, and dexamethasone) for people with relapsed or refractory multiple myeloma (RRMM).

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

First, we will make sure you are able to take part by reviewing your medical history, doing a physical exam, and running some tests. If you are able to take part, you will receive the study medications. You will then follow up with the study team regularly.

Incentives

You or your insurance provider will NOT have to pay for the isatuximab while you take part in this study.

Total length of participation:
Length of participation will depend how long you will take the study treatment and how you respond to it.

Looking for Specific Volunteers

Able to participate:

You have documented symptomatic Multiple Myeloma that has previously responded to therapy but is now relapsed or refractory to the last line of therapy.
You have predicted high risk for severe toxicity from intensive regimens for Relapsed/Refractory Multiple Myeloma.
You have measurable disease.
If you require radiotherapy, you have completed the therapy 14 days prior to initiating study therapy.
You have adequate bone marrow, kidney, and liver function.

Not eligible if:

You have received an anti-myeloma treatment within two weeks of starting study therapy.
You have had prior treatment with pomalidomide.
You have had monoclonal antibody therapy within the last 30 days.
You have had anti-CD38 monoclonal antibody therapy within the last six months.
You have had an autologous stem cell transplant within 12 weeks of starting study therapy.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Trials Office
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Secondary Visit Location

UNC Hospitals Hillsborough Campus
460 Waterstone Dr, Hillsborough, NC 27278, USA

Additional Study Information

Principal Investigator

Eben Lichtman
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Multiple Myeloma)

IRB Number

22-2429

ClinicalTrials.gov

NCT05911321