Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vanderbilt-Ingram Cancer Center
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Confirmed Multiple Myeloma as defined below within 120 days of starting cycle 1:
Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma
ECOG PS 0, 1 or 2
For women of childbearing potential a negative serum pregnancy test is required within 4 weeks of starting cycle 1 and then every 4 weeks during the first 4 cycles of induction therapy
Women of child bearing potential must be willing to refrain from sexual intercourse or willing to employ a dual method of contraception, one of which is highly effective (IUD, birth control pills, tubal ligation or partner's vasectomy) and another additional method (condom, diaphragm, or cervical cap) during the entire course of the study (start of therapy until 30 days after stem cell transplant).
Sexually active males should be willing to use a condom (even if they have had a prior vasectomy) while having intercourse with any women during the course of the study (start of therapy until 30 days after stem cell transplant).
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
You may not be if
In addition patient must have one of the following organ dysfunction criteria
Hypercalcemia
Renal insufficiency
Anemia
Bone disease manifested by lytic lesion or osteoporosis (if osteoporosis is the only organ dysfunction criteria then BM should have ≥ 30% plasma cells)
Confirmed Multiple myeloma as defined above within 90 days of starting cycle 1
The following study assessments must be fulfilled and must be obtained with four weeks of starting cycle 1
Hemoglobin \> 7 g/dL, Platelet count \> 75 X 10 to 9th power/L, and Absolute neutrophil count \> 1 X 10 to 9th power/L
SGPT (ALT) and SGOT (AST) ≤ 2.5 times the upper limit of normal
Ejection fraction ≥ 45% as measured by a MUGA scan or 2 D echocardiogram
Pulmonary function tests show \>60% predicted values for FVC, FEV1, and DLCO FEV1 must be \> 1 liter.
No prior systemic therapy with the exception of bisphosphonates for MM
Prior glucocorticoid therapy for the treatment of multiple myeloma is not permitted EXCEPT if used in conjunction with palliative radiation to prevent vasogenic edema. In that case steroids should have been used for less than 7 days. Prior steroid use for non-malignant disorders is permitted and should have been restricted to less than the equivalent of prednisone 10 mg per day. Prior or concurrent topical or localized steroid therapy to treat non-malignant disorders is permitted
Prior palliative and/ or localized radiation therapy is permitted provided at least 4 weeks have passed from date of last radiation therapy to starting cycle 1.
Patient has \> 1.5 × ULN Total Bilirubin
Grade 2 or higher peripheral neuropathy due to ANY cause
High index of suspicion of primary amyloid light chain (AL) amyloidosis.
Patients with uncontrolled inter-current illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance or a prior history of Steven Johnson syndrome
Patients must not have a history of current or previous deep vein thrombosis or pulmonary embolism regardless of whether or not the patient is receiving anticoagulation therapy
Female patients who are breastfeeding or pregnant.
Patients known to be HIV positive
Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 31.3), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
Patient has hypersensitivity to VELCADE, boron or mannitol.
Patient has received other investigational drugs within 14 days before enrollment
Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Clareo Health | First Autologous Transplant on Minimal Residual Disease Markers in Previously Untreated Myeloma Undergoing Initial Treatment With Velcade
