Study of Melphalan Flufenamide (Melflufen) in Combination With Daratumumab in Relapsed Refractory Multiple Myeloma (LIGHTHOUSE)

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Overview

This is a randomized, controlled, open-label, Phase 3 multicenter study which will enroll patients that have Relapsed Refractory Multiple Myeloma and are double refractory to an Immunomodulatory Drug (IMiD) and a Proteasome Inhibitor (PI) (regardless of the number of prior lines of therapy), or have received at least 3 prior lines of therapy including an IMiD and a PI.

SparkCures ID 1172
Trial Phase Phase 3
Enrollment 54 Patients
Treatments
Trial Sponsors
  • Oncopeptides AB
NCT Identifier

NCT04649060

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • A prior diagnosis of multiple myeloma with documented disease progression after last line of therapy
  • Double refractory to an immunomodulatory drug (IMiD) and a Proteasome Inhibitor (PI) (regardless of the number of prior lines of therapy), or have received at least 3 prior lines of therapy including an IMiD and a PI.
  • Prior treatment with daratumumab or another anti-CD38 antibody may be allowed under certain circumstances
  • Male and women of childbearing potential agrees to use contraception during the treatment period and during a specified time period after the last dose

Exclusion criteria:

  • Primary refractory disease (i.e. never responded with at least Minimal Response to any prior therapy for multiple myeloma)
  • Prior treatment with CD38 CAR-T cell therapy or CD38/CD3 bispecific antibodies
  • Any medical condition that may interfere with safety or participation in this study
  • Other malignancy diagnosed or requiring treatment within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast or very low and low risk prostate cancer in active surveillance
  • Known or suspected amyloidosis, plasma cell leukemia or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes)
  • Known central nervous system (CNS) or meningeal involvement of myeloma
  • Prior stem cell transplant (autologous and/or allogenic) within 6 months of initiation of therapy or prior allogeneic stem cell transplantation with active graft-versus-host-disease
  • Prior treatment with melflufen

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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