A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens

Overview

The hypothesis is that the addition of daratumumab administered SC to standard multiple myeloma regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin. Safety will be measured by adverse events, laboratory test results, electrocardiogram (ECGs), vital sign measurements, physical examination findings, SC injection-site assessments, and assessment of Eastern Cooperative Oncology Group (ECOG) performance status score. Study will consist of 3 phases (screening, treatment and follow-up) and duration of study is approximately 3 years.

SparkCures ID 967
Trial Phase Phase 2
Enrollment 240 Patients
Treatments
Tags
Trial Sponsors
  • Janssen Research & Development
NCT Identifier

NCT03412565

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:

  • Multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria
  • Measurable, secretory disease as defined by any of the following:
    1. Serum monoclonal paraprotein (M-protein) level greater than or equal to (≥) 1.0 gram per deciliter (g/dL); or
    2. Urine M-protein level ≥ 200 milligram per 24 hours (mg/24 hours); or
    3. Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) ≥ 10 mg/dL and abnormal FLC ratio
  • Meets one of the sets of the following criteria:
    1. For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma
    2. For Daratumumab + lenalidomide + dexamethasone (D-Rd) regimen: relapsed or refractory disease
  • Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0, 1, or 2
  • During the study, and for 3 months after receiving the last dose of daratumumab, a woman must agree not to donate eggs (ova, oocytes) and men must agree not to donate sperm for the purposes of assisted reproduction

Exclusion Criteria:

  • History of malignancy (other than MM) unless all treatment of that malignancy was completed at least 2 years before consent and the participant 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
  • Exhibits clinical signs of meningeal involvement of MM
  • Either of the following:
    1. Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is less than (<) 50 % of predicted normal
    2. Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification
  • Any of the following:
    1. Known to be seropositive for human immunodeficiency virus;
    2. Known to be seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (participants who are positive for antibodies to hepatitis B core antigen [antiHBc] and/or antibodies to hepatitis B surface antigen [antiHBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels . Those who are polymerase chain reaction (PCR) positive will be excluded
  • Known to be seropositive for hepatitis C (anti-HCV antibody positive or HCV-RNA quantitation positive) 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.

Mayo Clinic (Jacksonville)

Jacksonville, FL

Orlando Health UF Health Cancer Center

Orlando, FL

Providence Hospital

Southfield, MI

Nebraska Cancer Specialists (Omaha)

Omaha, NE

Avera Cancer Institute

Sioux Falls, SD

Utah Cancer Specialists UCS Cancer Center

Salt Lake City, UT

Florida
Mayo Clinic (Jacksonville)

Jacksonville, FL

Orlando Health UF Health Cancer Center

Orlando, FL

Michigan
Providence Hospital

Southfield, MI

Montana
Nebraska
Nebraska Cancer Specialists (Omaha)

Omaha, NE

New York
North Carolina
South Dakota
Avera Cancer Institute

Sioux Falls, SD

Utah
Utah Cancer Specialists UCS Cancer Center

Salt Lake City, UT

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

There are no resources, links or videos to display for this clinical trial.