Study on Bendamustine, Pomalidomide, and Dexamethasone for Treating Relapsed or Refractory Multiple Myeloma

Sponsor: Cristina Gasparetto

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01754402

Provider View

This clinical trial is testing a combination of three drugs—Bendamustine, Pomalidomide, and Dexamethasone—to find the best dose and see how well they work together in treating patients with multiple myeloma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

This study is designed to find the best dose and effectiveness of a combination treatment for multiple myeloma, a type of blood cancer. The treatment includes three drugs: Bendamustine, Pomalidomide, and Dexamethasone. Patients will receive these drugs in cycles of 28 days. After six cycles, the dose of Dexamethasone may be reduced, and after 12 cycles, patients will continue with Pomalidomide and Dexamethasone until the disease progresses.

Description

The main goals of this study are to find the safest and most effective dose of the drug combination and to see how well it works in shrinking the cancer. The study will involve up to 56 patients, starting with small groups to test different doses. Patients will receive the treatment in cycles, and their response to the treatment will be closely monitored.

The study will look at how long patients can go without the cancer getting worse and how long they can stay on the treatment. If the cancer progresses or if there are unacceptable side effects, the treatment may be stopped.

Patients will be evaluated for any side effects during the first cycle of treatment. If severe side effects occur, the dose may be adjusted. The study will also monitor how well the treatment works in reducing the cancer.

Patients must meet certain health criteria to participate, including having a confirmed diagnosis of multiple myeloma, being over 18 years old, and having a life expectancy of more than three months. Women of childbearing potential must use effective birth control, and men must use condoms during the study.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of multiple myeloma.
  • Cancer has returned or not responded to recent treatments.
  • Previously did not respond to lenalidomide treatment.
  • Measurable disease based on specific medical tests.
  • Evidence of cancer progression or relapse.
  • Age over 18 years.
  • Life expectancy of more than three months.
  • Good overall health with a performance status of 0-2.
  • Acceptable liver and kidney function based on blood tests.
  • Adequate blood cell counts.
  • Agree to take aspirin daily.
  • Willing to provide informed consent.
  • Women must have a negative pregnancy test and use birth control.
  • Men must use condoms and not donate sperm during the study.
  • Register with POMALYST REMS™ program and follow its requirements.

Exclusion Criteria

  • Known allergy to the study drugs.
  • Recent use of experimental drugs or treatments.
  • Recent chemotherapy or steroid use.
  • Previous use of pomalidomide.
  • Recent radiation therapy.
  • Certain medical conditions like POEMS syndrome or plasma cell leukemia.
  • Recent major surgery.
  • Pregnant or breastfeeding women.
  • Serious heart conditions or recent heart attack.
  • Uncontrolled high blood pressure.
  • Active infections requiring treatment.
  • Recent treatment for other cancers.
  • Serious psychiatric or medical conditions.
  • Severe nerve damage.
  • Cannot take required additional medications.
  • Primary systemic amyloidosis.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.