Early Access to Daratumumab Treatment for Patients with Relapsed or Hard-to-Treat Multiple Myeloma

Sponsor: Janssen Research & Development, LLC

Expanded Access
Approved for Marketing
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT02477891

Provider View

This study offers early access to the drug daratumumab for patients with multiple myeloma who have tried at least three other treatments without success. The trial aims to gather more safety information about the drug while it is not yet widely available.

Patient Parameters

Program Overview

The purpose of this study is to provide early access to the drug daratumumab for patients with multiple myeloma who have already tried at least three different treatments, including a proteasome inhibitor and an immunomodulatory agent, or whose disease is resistant to both. This study is for patients who cannot access daratumumab through other means. Participants will receive the drug through an IV infusion and will be monitored for safety and response to the treatment.

Description

This study is designed to give patients with multiple myeloma early access to the drug daratumumab, which is not yet widely available. It is open to patients who have tried at least three other treatments, including a proteasome inhibitor and an immunomodulatory agent, or whose disease is resistant to both. The study is conducted at multiple centers and is open-label, meaning both the researchers and participants know what treatment is being given.

The study has three phases:

  • Screening Phase: This occurs 30 days before the first dose of the study drug to ensure participants meet all criteria.
  • Treatment Phase: Participants will receive daratumumab through an IV infusion until their disease progresses, they experience unacceptable side effects, or the study ends.
  • End of Treatment: This phase occurs 30 days after the last dose of the study drug.

Participants will be monitored for their overall response to the treatment and for any safety concerns throughout the study.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of multiple myeloma and show disease progression after the most recent treatment.
  • Must have tried at least three previous treatments, including a proteasome inhibitor and an immunomodulatory agent, or have disease resistant to both.
  • Must have a performance status score of 0, 1, or 2, indicating they are fully active or have some limitations but are still able to care for themselves.
  • Women of childbearing potential must have a negative pregnancy test before starting the study.
  • Men who are sexually active with women of childbearing potential must use a barrier method of birth control and must not donate sperm during the study and for six months after the last dose.

Exclusion Criteria

  • Have participated in another daratumumab study or are eligible for another ongoing daratumumab study.
  • Are receiving any other treatment for multiple myeloma while on daratumumab.
  • Are enrolled in another clinical study with therapeutic intent.
  • Have chronic obstructive pulmonary disease (COPD) with significant breathing difficulties.
  • Have moderate or severe asthma in the past two years or currently have uncontrolled asthma.
  • Have previously been treated with any anti-CD38 monoclonal antibody.

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