Study on Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone for Newly Diagnosed Multiple Myeloma

Sponsor: Jacob Laubach, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04653246

Provider View

This clinical trial is testing a new combination of drugs, including isatuximab, to see if it is safe and effective for treating patients who have been newly diagnosed with multiple myeloma, a type of blood cancer.

Patient Parameters

Program Overview

The purpose of this study is to find out if a new drug called isatuximab, when combined with other standard chemotherapy drugs (lenalidomide, bortezomib, and dexamethasone), is safe and effective for treating people who have just been diagnosed with multiple myeloma. This study is in Phase II, which means it is focused on testing the safety and effectiveness of this drug combination. While the other drugs are already approved for treating multiple myeloma, the combination with isatuximab is still being studied.

Description

This study involves a combination of four drugs to treat newly diagnosed multiple myeloma, a type of cancer that affects the blood. The drugs include isatuximab, which is being tested, along with lenalidomide, bortezomib, and dexamethasone, which are standard treatments. The study is open to patients who are eligible for high-dose therapy and a stem cell transplant. Participants will receive this combination of drugs to see if it is safe and effective in treating their cancer. The study is being conducted at multiple centers and is open-label, meaning both the researchers and participants know which treatment is being given. The U.S. Food and Drug Administration (FDA) has approved lenalidomide, bortezomib, and dexamethasone for multiple myeloma, but the combination with isatuximab is still under investigation.

Eligibility Criteria

Inclusion Criteria

  • Must have been diagnosed with multiple myeloma and need treatment.
  • Must be willing to provide written consent to participate in the study.
  • Must be 75 years old or younger, with special approval needed for those over 70.
  • Must have measurable disease, such as specific levels of proteins in the blood or urine.
  • Must have certain blood counts and organ function within specified limits.
  • Must have a performance status score of 2 or less, indicating they are able to carry out daily activities with some limitations.
  • Must agree to participate in a safety program for one of the study drugs.
  • Must be eligible for a stem cell transplant according to their doctor.

Exclusion Criteria

  • Have received prior treatment for multiple myeloma.
  • Have been diagnosed or treated for another cancer within the last 3 years, except for certain skin cancers or low-risk prostate cancer.
  • Have cancer that has spread to the brain or spinal cord.
  • Have severe nerve damage or pain.
  • Have any medical or mental health condition that would make participation risky.
  • Have uncontrolled heart conditions or recent heart problems.
  • Have had major surgery or radiation therapy recently.
  • Require daily steroids above a certain dose.
  • Have certain blood disorders or infections.
  • Are pregnant or breastfeeding, or planning to become pregnant.
  • Are unable to use effective birth control methods.
  • Are taking other experimental drugs.
  • Have allergies to any of the study drugs or their components.

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