Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab Intravenous (Dara-IV)

Overview

The purpose of this study is to compare the efficacy (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab intravenous (Dara-IV) to evaluate daratumumab retreatment.

SparkCures ID 1014
Trial Phase Phase 2
Enrollment 230 Patients
Treatments
Trial Sponsors
  • Janssen Research & Development
NCT Identifier

NCT03871829

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:

  • Evidence of a response (partial response or better based on investigator's determination of response by International Myeloma Working Group [IMWG] criteria) to daratumumab-containing intravenously (IV) therapy with response duration of at least 4 months
  • Relapsed or refractory disease as defined as: a) Relapsed disease is defined as an initial response to previous treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than (>) 60 days after cessation of treatment. b) Refractory disease is defined as less than (<) 25 percent (%) reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or >60 days after cessation of treatment
  • Received 1 or 2 prior line(s) of treatment of which one contained Dara IV, and completed Dara IV at least 3 months prior to randomization. A single line of therapy may consist of 1 or more agents, and may include induction, hematopoietic stem cell transplantation, and maintenance therapy. Radiotherapy, bisphosphonate, or a single short course of corticosteroids (no more than the equivalent of dexamethasone 40 milligram per day [mg/day] for 4 days) would not be considered prior lines of therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
  • Women of childbearing potential must have a negative urine or serum pregnancy test at screening within 14 days prior to randomization

Exclusion Criteria:

  • Previous treatment with daratumumab within the last 3 months prior to randomization
  • Discontinuation of Dara IV due to a daratumumab-related adverse event (AE)
  • History of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the patient has no evidence of disease. Further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years
  • Allergies, hypersensitivity, or intolerance to daratumumab, hyaluronidase, monoclonal antibodies (mAbs), human proteins, or their excipients, or known sensitivity to mammalian-derived products. Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib)
  • Participant is: a) Known to be seropositive for human immunodeficiency virus. b) Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (example: participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. c) Known to be seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy)

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

The Oncology Institute of Hope and Innovation

Tucson, AZ

American Institute of Research (AIR)

Whittier, CA

Fort Wayne Medical Oncology and Hematology - Fort Wayne North Office

Fort Wayne, IN

Millennium Oncology - Northwest Houston

Houston, TX

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

Mayo Clinic (Rochester)

Rochester, MN

Arizona
The Oncology Institute of Hope and Innovation

Tucson, AZ

California
American Institute of Research (AIR)

Whittier, CA

Indiana
Fort Wayne Medical Oncology and Hematology - Fort Wayne North Office

Fort Wayne, IN

Michigan
Minnesota
Mayo Clinic (Rochester)

Rochester, MN

Missouri
New York
Ohio
Texas
Millennium Oncology - Northwest Houston

Houston, TX

International Locations

This trial has active trial locations in countries outside of the United States.

Our system currently only provides clinical trial matching services for myeloma patients in the United States.

You can view this clinical trial's international locations by visiting ClinicalTrials.gov. Please be aware that the government website may include information that is inaccurate and/or out-of-date.

Resources

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