A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

Overview

This study will evaluate participants with newly diagnosed multiple myeloma (MM) for whom hematopoietic stem cell transplant is not planned as initial therapy. The data available from other available studies suggests that addition of daratumumab with Velcade (bortezomib), lenalidomide, and dexamethasone [VRd] is anticipated to improve the response rates and the depth of response and may lead to improved long-term outcomes in newly diagnosed participants with MM.

Daratumumab targets CD38, a protein expressed on the surface of MM cells and other hematopoietic cells. Bortezomib is a proteasome inhibitor, which plays a critical role in the pathogenesis of MM. Lenalidomide has cytotoxic effects on myeloma cells and is capable of inducing apoptosis, or programmed cell death and dexamethasone induces apoptosis in MM cells.

The rationale for the study is to utilize the subcutaneous (SC) formulation of daratumumab instead of the intravenous (IV) formulation, which is expected to provide similar exposure and is expected to limit additional toxicity to participants, treated with this quadruplet regimen.

The study will consist of 3 phases: Screening (up to 28 days before randomization), Treatment phase (from Cycle 1 [21 days] Day 1 and continues until disease progression) and Follow up (Postintervention). Efficacy evaluations will include measurements of tumor burden/residual disease, myeloma proteins, bone marrow examinations, skeletal surveys, extramedullary plasmacytomas, and serum calcium corrected for albumin. Participants will undergo procedures like electrocardiogram (ECG), chest x-rays or full dose chest CT scans, Pulmonary function test (PFT), spirometry etc. during the course of study. Participants will also be monitored closely for adverse events (AEs), laboratory abnormalities, and clinical response. The duration of the study will be approximately 6.5 years.

SparkCures ID 981
Trial Phase Phase 3
Enrollment 360 Patients
Treatments
Trial Sponsors
  • Janssen Research & Development
NCT Identifier

NCT03652064

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:

  • Diagnosis of multiple myeloma as documented per International Myeloma Working Group (IMWG) criteria Monoclonal plasma cells in the bone marrow greater than or equal to (>=)10 percentage (%) or presence of a biopsy proven plasmacytoma and documented multiple myeloma satisfying at least one of the calcium, renal, anemia, bone (CRAB) criteria or biomarkers of malignancy criteria. CRAB criteria: Hypercalcemia: serum calcium greater than (>) 0.25 millimoles per liter (mmol/L) (>1 milligram per deciliter [mg/dL]) higher than upper limit of normal (ULN) or >2.75 mmol/L (>11 mg/dL); Renal insufficiency: creatinine clearance less than (<) 40 milliliter per minute (mL/min) or serum creatinine >177 micro millimoles per liter (umol/L) (>2 mg/dL); Anemia: hemoglobin >2 g/dL below the lower limit of normal or hemoglobin <10 g/dL; Bone lesions: one or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)-CT.

Biomarkers of Malignancy: Clonal bone marrow plasma cell percentage >=60%; Involved: uninvolved serum free light chain (FLC) ratio >=100; >1 focal lesion on magnetic resonance imaging (MRI) studies

  • Must have measurable disease, as assessed by central laboratory
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
  • A woman of childbearing potential must have 2 negative serum or urine pregnancy tests at Screening, first within 10 to 14 days prior to dosing and the second within 24 hours prior to dosing
  • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 3 months after receiving the last dose of any component of the treatment regimen

Exclusion Criteria:

  • Frailty index of >=2 according to Myeloma Geriatric Assessment score
  • Prior therapy for multiple myeloma other than a short course of corticosteroids (not to exceed 40 mg of dexamethasone, or equivalent per day for a maximum of 4 days, total of 160 mg dexamethasone or equivalent)
  • Prior or concurrent invasive malignancy (other than multiple myeloma) within 5 years of date of randomization (exceptions are adequately treated basal cell or squamous cell carcinoma of the skin, 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)
  • Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5
  • Radiation therapy within 14 days of randomization

US Trial Locations

Accepting Patients

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

Innovative Clinical Research Institute

Whittier, CA

Baptist MD Anderson

Jacksonville, FL

Fort Wayne Medical Oncology and Hematology
Fort Wayne North Office

Fort Wayne, IN

Norton Cancer Institute
St. Matthews Campus

Louisville, KY

Tufts Medical Center Cancer Center

Boston, MA

Cancer and Hematology Centers of Western Michigan (Grand Rapids)

Grand Rapids, MI

Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey

New Brunswick, NJ

San Juan Oncology Associates

Farmington, NM

NYU Winthrop Hospital

Mineola, NY

Good Samaritan Hospital Corvallis

Corvallis, OR

Gibbs Cancer Center and Research

Spartanburg, SC

UVA Cancer Center
University of Virginia Health System

Charlottesville, VA

Not Currently Accepting Patients

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

Miami VA Medical Center

Miami, FL

Boston University Medical Center

Boston, MA

Saint Luke's Hospital of Kansas City

Kansas City, MO

Durham Veterans Affairs Medical Center

Durham, NC

Weill Cornell Medicine

New York, NY

California
Innovative Clinical Research Institute

Whittier, CA

Florida
Baptist MD Anderson

Jacksonville, FL

Miami VA Medical Center

Miami, FL

Indiana
Fort Wayne Medical Oncology and Hematology
Fort Wayne North Office

Fort Wayne, IN

Kentucky
Norton Cancer Institute
St. Matthews Campus

Louisville, KY

Massachusetts
Tufts Medical Center Cancer Center

Boston, MA

Boston University Medical Center

Boston, MA

Michigan
Cancer and Hematology Centers of Western Michigan (Grand Rapids)

Grand Rapids, MI

Missouri
Saint Luke's Hospital of Kansas City

Kansas City, MO

New Jersey
Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey

New Brunswick, NJ

New Mexico
San Juan Oncology Associates

Farmington, NM

New York
NYU Winthrop Hospital

Mineola, NY

Weill Cornell Medicine

New York, NY

North Carolina
Durham Veterans Affairs Medical Center

Durham, NC

Ohio
Oregon
Good Samaritan Hospital Corvallis

Corvallis, OR

Pennsylvania
South Carolina
Gibbs Cancer Center and Research

Spartanburg, SC

Texas
Virginia
UVA Cancer Center
University of Virginia Health System

Charlottesville, VA

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 note the information provided through the government website may be inaccurate and/or out-dated.

Resources

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