This research study is a Pilot Study, which is the first time investigators are examining this study drug in your specific disease. The purpose of this research study is to learn whether daratumumab works in treating your MGUS or SMM. Patients with MGUS and SMM do not have symptoms but are at risk for progressing to active multiple myeloma.
Multiple myeloma is a cancer of the plasma cell, which is an important part of the immune system. Patients with active multiple myeloma generally require treatment. There are currently no approved therapies for smoldering multiple myeloma or Monoclonal Gammopathy of Unknown Significance. Daratumumab is a drug that may kill or stop cancer cells from growing through a variety of mechanisms by attaching to the CD38 molecule, which is over-expressed in multiple myeloma cells. This type of drug is called a monoclonal antibody. The FDA (the U.S. Food and Drug Administration) has not approved Daratumumab for the participant specific disease but it has been approved for use in active Multiple Myeloma.
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.
Must have <10% plasma cells and <3.0g/dL M-spike and at least 2 of the following 3 criteria:
Low-Risk Smoldering Multiple Myeloma
Must only present with 1 of the following criterion:
Monoclonal Protein ≥ 3 g/dL
---≥ 10% Bone Marrow Plasma Cells
FLC ratio < 0.125 or > 8
-No evidence of CRAB criteria† or new criteria of active MM which including the following:
No evidence of the following new criteria for active MM including the following: Bone marrow plasma cells >60%, Serum involved/uninvolved FLC ratio ≥100, and MRI with more than one focal lesion
Creatinine ≤ 2 mg/dL or Creatinine Clearance ≥ 40 mL/min
---Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months)
Note that FEV1 testing is required for patients suspected of having COPD and subjects must be excluded if FEV1 <50% of predicted normal.
The following is a listing of trial locations that are open and accepting patients.
There are no resources, links or videos to display for this clinical trial.