Short Course Daratumumab in Patients With Multiple Myeloma

Overview

The purpose of this study is to test the safety of short course Daratumumab in combination with lenalidomide and to find out what effects, if any, short course Daratumumab in combination with lenalidomide has on people and their risk of multiple myeloma. The study is also designed to test the amount of remaining myeloma cells in your body after treatment with daratumumab which is known as minimal residual disease (MRD).

SparkCures ID 948
Trial Phase Phase 2
Enrollment 25 Patients
Treatments
Trial Sponsors
  • Janssen Research & Development
NCT Identifier

NCT03490344

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 according to the International Myeloma Working Group definition i.e.:Clonal bone marrow plasma cells ≥ 10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma defining events and/or one or more of the biomarkers for malignancy at the time of diagnosis:
    • Myeloma defining events:
    • Hypercalcemia: serum calcium >0.25 mmol/L (>1 mg/dL) higher than the upper limit of normal or >2.75 mmol/L (>11 mg/dL)
    • Renal insufficiency: creatinine clearance <40 mL per min or serum creatinine >177 µmol/L (>2 mg/dL)
    • Anemia: hemoglobin value of >20 g/L below the lower limit of normal, or a hemoglobin value <100 g/L
    • Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT
    • Biomarkers of malignancy:
    • Clonal bone marrow plasma cell percentage ≥60%
    • Involved: uninvolved serum free light chain ratio≥100
    • >1 focal lesions on MRI studies
  • A very good partial response (VGPR) or better after induction therapy with/without consolidative HDT/ASCT.
    • Very good partial response (VGPR):
    • Serum and urine M-component detectable by immunofixation but not on electrophoresis or
    • ≥90% or greater reduction in serum M-component plus urine M-component <100 mg per 24 h
    • Complete response (CR):
    • Negative immunofixation of serum and urine and
    • Disappearance of any soft tissue plasmacytomas and
    • <5% plasma cells in bone marrow
    • Stringent complete response (sCR)
    • CR as defined above plus
    • Normal free light chain ratio and
    • Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence
    • MRD positive by flow cytometry
  • Additionally, patients who were previously MRD negative for >/= 3 months after induction therapy with/without consideration HDT/ASCT and have turned MRD positive (by flow cytometry) within the last 3 months and do not have any evidence of progressive disease are eligible.
  • Patients must be on standard of care lenalidomide maintenance therapy for at least 6 months at the time of study enrollment
  • Patient can be receiving bisphosphonate therapy per the treating oncologist's discretion
  • Creatinine clearance ≥60 ml/min using the Cockcroft-Gault method, MDRD, or CKD-EPI formula. If the calculated CrCl based on Cockcroft-Gault method, MDRD, or CKD-EPI is <60 mL/min, patient will have a 24 hr urine collection to measure CrCl.
  • Age ≥18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Male or female patient who accepts and is able to use recognised effective contraception (oral contraceptives, IUCD, barrier method of contraception in conjunction with spermicidal jelly) throughout the study when relevant.
  • Absolute neutrophil count (ANC) ≥1.0 x 10^9/L, hemoglobin ≥8 g/dL, and platelet count ≥75 x 10^9/L. No transfusion or growth factor support for one week prior to labs.
  • Adequate hepatic function, with bilirubin < 1.5 x the ULN, and AST and ALT < 2.5 x ULN

Exclusion Criteria:

  • Patients with a diagnosis of MM not achieving a VGPR or better to the most recent therapy.
  • Patients must not have measurable disease at the time of enrollment. Measurable disease is defined as follows
    • Serum monoclonal protein > 1gm/dL
    • Urine monoclonal protein > 200 mg/24 hours
    • Involved serum free light chain > 10 mg/dL
  • Pregnant or lactating females
  • Uncontrolled hypertension or diabetes
  • Active hepatitis B or C infection
  • Has significant cardiovascular disease with NYHA Class III or IV symptoms, or hypertrophic cardiomegaly, or restrictive cardiomegaly, or myocardial infarction within 3 months prior to enrollment, or unstable angina, or unstable arrhythmia
  • Uncontrolled intercurrent illness including but not limited to active infection or psychiatric illness/social situations that would compromise compliance of study requirements
  • Contraindication to any concomitant medication, including antivirals, anticoagulation prophylaxis, tumor lysis prophylaxis, or hydration given prior to therapy
  • Active infection requiring treatment within two weeks prior to first dose

US Trial Locations

Accepting Patients

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

Memorial Sloan Kettering Cancer Center

Basking Ridge, NJ

Memorial Sloan Kettering Cancer Center

Middletown, NJ

Memorial Sloan Kettering Cancer Center

Commack, NY

Memorial Sloan Kettering Cancer Center
Rockville Centre

Rockville Centre, NY

Memorial Sloan Kettering Cancer Center
Westchester in West Harrison

West Harrison, NY

New Jersey
Memorial Sloan Kettering Cancer Center

Basking Ridge, NJ

Memorial Sloan Kettering Cancer Center

Middletown, NJ

New York
Memorial Sloan Kettering Cancer Center

Commack, NY

Memorial Sloan Kettering Cancer Center
Rockville Centre

Rockville Centre, NY

Memorial Sloan Kettering Cancer Center
Westchester in West Harrison

West Harrison, NY

Resources

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