Study on the Safety of HDP-101 for Patients with Relapsed or Hard-to-Treat Multiple Myeloma

Sponsor: Heidelberg Pharma AG

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04879043

Provider View

This clinical trial is evaluating the safety and potential benefits of a new treatment, HDP-101, for patients with multiple myeloma and other related plasma cell disorders that have not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to test the safety and effectiveness of a new drug, HDP-101, in patients with multiple myeloma and similar conditions. The study will be conducted in two parts: the first part will determine the best dose of the drug, and the second part will further test its safety and how well it works against the cancer.

Description

This study is divided into two phases. In the first phase, researchers will gradually increase the dose of HDP-101 to find the safest and most effective amount for patients with relapsed or hard-to-treat multiple myeloma or other plasma cell disorders. This phase will use a special method to ensure the dose is safe and effective.

In the second phase, the study will expand to include more patients to gather more information on how well HDP-101 works as a standalone treatment and to confirm its safety. The goal is to see if HDP-101 can help reduce the cancer in patients who have already tried other treatments without success.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Expected to live for more than 12 weeks.
  • Have a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a confirmed diagnosis of active multiple myeloma.
  • Must have had a stem cell transplant or be considered ineligible for one.
  • Must have tried previous treatments for multiple myeloma, including specific types of drugs, and either not responded or cannot tolerate standard treatments.
  • Have measurable disease according to specific criteria.
  • Have adequate organ function as defined in the study protocol.

Exclusion Criteria

  • For the second phase of the study only: Cannot have had previous treatments targeting BCMA.
  • Cannot have cancer that has spread to the brain.
  • Cannot have plasma cell leukemia.
  • Cannot have a history of heart failure.
  • Cannot have had a stem cell transplant within 12 weeks before starting the study or be planning one.
  • Cannot have symptoms of graft versus host disease after a stem cell transplant within 12 months before starting the study.
  • Cannot have had radiation therapy within 21 days before starting the study.
  • Cannot have any other active cancer.
  • Cannot have HIV.
  • Cannot have an active infection requiring treatment.
  • Cannot test positive for hepatitis B or C.
  • Cannot have active liver or bile duct disease.

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