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Daratumumab, Thalidomide and Dexamethasone in Relapse and/or Refractory Myeloma

NCT03143036 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-06-07

No results posted yet for this study

Summary

Myeloma patients who relapse after prior treatment with bortezomib and lenalidomide have survival of less than 1 year. A number of new drugs have been approved for the treatment of relapse myeloma in the last couple of years, including, Elotuzumab, Panobinostat, Ixazomib, carfilzomib and Pomalidomide. However, most of these drugs either do not have good single agent activity or still belongs to the category of immunomodulatory drugs or proteasome inhibitors. Daratumumab is a monoclonal antibody against CD38 that is highly expressed on myeloma plasma cells. In phase ½ studies, it has impressive single agent activity in relapse and refractory myeloma with a very acceptable toxicity profile. This set the stage for combinations with daratumumab to increase efficacy and improve outcome of patients with myeloma. The use of immunomodulatory drugs, such as thalidomide and lenalidomide, has been shown to augment NK cell activity. NK cells are important mediator of antibody dependent cellular cytotoxicity. We therefore hypothesize that the combination of Daratumumab with thalidomide may therefore improve the efficacy of the treatment.

In this study, we will plan to perform a phase II trial using the Daratumumab, Thalidomide, Dexamethasone combination in 100 myeloma patients with relapse myeloma in Asia.

Conditions

  • Relapse and / or Refractory Myeloma

Interventions

DRUG

Daratumumab, thalidomide and dexamethasone

Patients will be treated with with the following schedule. IV daratumumab 16mg/kg body weight weekly for weeks 1-8 followed by daratumumab 16mg/kg body weight once every 2 weeks from weeks 9 to 24 and then daratumumab 16mg/kg once every 4 weeks from weeks 25 onwards until disease progression; PO thalidomide 100mg daily for 1 year and PO Dexamethasone 40mg (starting dose of dexamethasone is 20mg once weekly for patients \>75 years old) once weekly for 1 year (13 cycles, each cycle is 4 weeks). After 1 year, patient only continue on daratumumab until progression Patients will be assessed every 28 days (+/-10 days).

Sponsors & Collaborators

  • Janssen, LP

    collaborator INDUSTRY

  • International Myeloma Foundation

    collaborator OTHER

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Wee Joo Chng · National University Hospital, Singapore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2019-07-01
Completion
2022-07-01

Countries

  • Hong Kong
  • Singapore
  • South Korea
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03143036 on ClinicalTrials.gov