Comparing Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) with Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06169215

Provider View

This study is testing a new combination of drugs to see if it works better than the usual treatment for patients with high-risk newly diagnosed multiple myeloma, a type of blood cancer. The new combination includes selinexor, daratumumab, Velcade, and dexamethasone, while the usual treatment includes daratumumab, lenalidomide, Velcade, and dexamethasone.

Patient Parameters

Program Overview

This phase II clinical trial is comparing two treatment combinations for patients with high-risk newly diagnosed multiple myeloma. The new combination being tested includes selinexor, daratumumab, Velcade (bortezomib), and dexamethasone (Dara-SVD). The usual treatment includes daratumumab, lenalidomide, Velcade, and dexamethasone (Dara-RVD). Selinexor is a drug that may stop cancer cells from growing by blocking a protein called CRM1. Daratumumab is an antibody that helps the immune system attack cancer cells. Velcade and dexamethasone are drugs that help kill cancer cells and reduce inflammation. Lenalidomide helps the bone marrow produce normal blood cells and kill abnormal ones. All these drugs are approved for use in myeloma, but selinexor is usually used only after the cancer returns. This study is testing if using selinexor earlier can be more effective for high-risk patients.

Description

The main goal of this study is to see if the new treatment combination (Dara-SVD) can achieve a deep response in patients by the end of the fourth treatment cycle. This means the cancer is significantly reduced or undetectable. The study will also look at other outcomes like how long patients stay free of cancer and how long the treatment effects last.

Patients will be randomly assigned to one of two groups:

  • Group 1 (Dara-SVD): Patients will receive daratumumab, selinexor, Velcade, and dexamethasone. These drugs will be given in cycles, with each cycle lasting 28 days. Patients will also have scans and blood tests to monitor their progress.

  • Group 2 (Dara-RVD): Patients will receive daratumumab, lenalidomide, Velcade, and dexamethasone. These drugs will also be given in 28-day cycles, with similar monitoring through scans and blood tests.

After completing the treatment, patients will have follow-up visits at 6 months, 1 year, and 2 years to check on their health and the status of their cancer.

Eligibility Criteria

Inclusion Criteria

  • Must have newly diagnosed multiple myeloma.
  • Must have high-risk genetic features as identified by specific tests.
  • May have received one cycle of certain myeloma treatments if urgent therapy was needed.
  • Must be in good general health with a performance status of 0 to 2.
  • Must have adequate blood cell counts and organ function.
  • HIV-positive patients must have an undetectable viral load.
  • Hepatitis B and C infections must be under control or cured.
  • Women of childbearing potential must use effective birth control and have a negative pregnancy test.
  • Men must agree to use condoms and not donate sperm during and after treatment.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot have severe side effects from previous cancer treatments.
  • Cannot be taking other experimental drugs.
  • Cannot have allergies to the study drugs.
  • Cannot have uncontrolled health conditions that make participation unsafe.
  • Pregnant or breastfeeding women cannot participate due to potential risks to the baby.

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