• Home
  • Study Details
Open

Phase 2 study of isatuximab plus lenalidomide and dexamethasone in highly toxicity-vulnerable subjects with newly diagnosed multiple myeloma

The purpose of this study is to evaluate the safety and effectiveness of isatuximab when used in combination with lenalidomide and dexamethasone at lower doses. This study will test lower doses of these drugs to reduce the likelihood of any harmful side effects that may be experienced. The study team believes using this combination at lower doses, may help patients with newly diagnosed multiple myeloma achieve a better response while causing fewer or less severe side effects. To estimate the overall response rate (ORR) of the cancer in vulnerable subjects with newly-diagnosed multiple myeloma treated with Isa-Rd (a combination of the three above-listed drugs).

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

The study will be conducted in phases, participants must start with phase 1 and follow through the phases in order. Phase 1, Screening to Determine Eligibility: evaluation to see if you are a good fit for the study. Phase 2, Treatment with Isatuximab, Lenalidomide and Dexamethasone: Treatment will be offered in cycles. Each treatment cycle is 28 days long. (REVLIMID®) is the brand name for lenalodomide Phase 3, Maintenance: After completing 24 treatment cycles, participants will move into the maintenance phase where they will take lenalidomide only. This is the standard treatment for their type of cancer, as approved by FDA. Participants will continue taking lenalidomide for as long as it is working to control their myeloma and are tolerating the medication. Phase 4, Long-Term Follow-Up: if the participant stops receiving treatment for any reason, they will enter the follow-up phase of the study. Prior to starting this phase, they will have a clinic visit to complete a series of lab tests and assessments. The study team will use these tests to evaluate how the participant's myeloma responded to the treatment received. This study will involve the following tests and procedures: a review of medical history, physical exam, performance status review, pregnancy test, bone survey, tumor assessment (CT, MRI, or PET-CT), bone marrow biopsy, blood tests, isatuximab infusion, dexamethasone dose, lenalidomide dose, concomitant medications review, pill diary review, and questionnaires.

Incentives

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

In-person visits:
At least one screening visit, four visits during cycle 1, two visits during all subsequent cycles, one end of treatment visit, and one follow-up visit every 12 weeks while experiencing adverse events.
Total length of participation:
Approximately two years.

Looking for Specific Volunteers

Able to participate:

  • You have a predicted high risk for severe toxicity from intensive induction regimens.
  • You have diagnosed measurable multiple myeloma.
  • You have had no prior systemic anti-myeloma therapy lasing more than 28 days.
  • You have adequate bone marrow and kidney function.
  • You are willing to adhere to the study visit schedule and other requirements.

Not eligible if:

  • You have received radiation therapy within 14 days of receiving treatment on this study.
  • You are a woman who can have children and will not use two methods of highly effective birth control or abstain from heterosexual activity.
  • You are a man and you are not surgically sterile, will not use two methods of highly effective birth control or abstain from heterosexual activity.
  • You have Human Immunodeficiency Virus (HIV), Hepatitis A, Hepatitis B, or Hepatitis C infection.
  • You have had a heart attack within three months of receiving treatment on this study.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

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

Sascha Tuchman
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Multiple Myeloma)

IRB Number

21-1957

ClinicalTrials.gov

NCT05145400

Research for Me logo

Copyright © 2013-2022 The NC TraCS Institute, the integrated home of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC-CH.  This website is made possible by CTSA Grant UL1TR002489 and the National Center for Advancing Translational Sciences.

Questions?

  • This email address is being protected from spambots. You need JavaScript enabled to view it.
logo for the North Carolina Translational and Clinical Sciences Institute
logo for UNC Health
logo for UNC School of Medicine
logo for UNC Research