Multiple Myeloma | Transplantation Twice Scheduled | Autologous Transplantation Scheduled | Recurrent disease | Progressive Disease
Item
history of histologically documented mm with relapsed or progressive disease after either scheduled tandem or one autologous transplantation.
boolean
C0026764 (UMLS CUI [1])
C0040732 (UMLS CUI [2,1])
C1948050 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
C0040736 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
C0277556 (UMLS CUI [4])
C1335499 (UMLS CUI [5])
Measurable Disease
Item
patient has measurable disease in which to capture response.
boolean
C1513041 (UMLS CUI [1])
Zubrod Performance Status | Bone pain Zubrod Performance Status
Item
performance status of 2 as per zubroid scale, unless ps of 3-4 based solely on bone pain.
boolean
C3714786 (UMLS CUI [1])
C0151825 (UMLS CUI [2,1])
C3714786 (UMLS CUI [2,2])
Platelet Count measurement | Absolute neutrophil count
Item
patients must have a platelet count 75,000/μl, and an anc of at least 1,000/μl.
boolean
C0032181 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
Renal function | Creatinine measurement, serum
Item
patients must have adequate renal function defined as serum creatinine < 2.5 mg/dl.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver function | Transaminase Assay | Bilirubin, direct measurement
Item
patients must have adequate hepatic function defined as serum transaminases and direct bilirubin < 2 x the upper limit of normal.
boolean
C0232741 (UMLS CUI [1])
C0919834 (UMLS CUI [2])
C0201916 (UMLS CUI [3])
Pregnancy Exclusion | Breast Feeding Exclusion | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
pregnant or nursing women may not participate. women of childbearing potential must have a negative pregnancy documented within one week of registration. women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
boolean
C0032961 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Age
Item
male or female adults of at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Protocol Compliance
Item
patients must have signed an irb-approved written informed consent form and demonstrate willingness to meet follow-up schedule and study procedure obligations.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Chemotherapy | Therapeutic radiology procedure
Item
chemotherapy or radiotherapy received within the previous 2 weeks.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Neurotoxicity CTCAE Grades
Item
significant neurotoxicity, defined as grade > 2 neurotoxicity per nci common toxicity criteria (see appendix).
boolean
C0235032 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Platelet Count measurement | Absolute neutrophil count
Item
platelet count < 75,000/mm3, or anc < 1,000/μl.
boolean
C0032181 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
Liver Dysfunction | Elevated total bilirubin | Aspartate aminotransferase increased | Hepatitis
Item
clinically significant hepatic dysfunction as noted by bilirubin or ast > 3 times the upper normal limit or clinically significant concurrent hepatitis.
boolean
C0086565 (UMLS CUI [1])
C0741494 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0019158 (UMLS CUI [4])
Heart failure New York Heart Association Classification
Item
new york hospital association (nyha) class iii or class iv heart failure.
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Myocardial Infarction
Item
myocardial infarction within the last 6 months.
boolean
C0027051 (UMLS CUI [1])
Communicable Disease Uncontrolled | Intravenous antibiotic therapy Patient need for
Item
uncontrolled, active infection requiring iv antibiotics.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0559680 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Therapeutic procedure Ventricular arrhythmia
Item
patients with a history of treatment for clinically significant ventricular cardiac arrhythmias.
boolean
C0087111 (UMLS CUI [1,1])
C0085612 (UMLS CUI [1,2])
Poor hypertension control | Diabetes Mellitus | Illness Serious Interferes with Treatment completion | Mental disorder Interferes with Treatment completion
Item
poorly controlled hypertension, diabetes mellitus, or other serious or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
boolean
C0421190 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C0221423 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0580352 (UMLS CUI [3,4])
C0004936 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0580352 (UMLS CUI [4,3])
Pregnancy | Gender Fertility | Childbearing Potential Pregnancy Test Contraceptive methods
Item
pregnant or potential for pregnancy. women of childbearing potential will have a pregnancy test at screening, and will be required to use a medically approved contraceptive method.
boolean
C0032961 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0015895 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
Breast Feeding
Item
breast-feeding women may not participate.
boolean
C0006147 (UMLS CUI [1])