NIH | National Cancer Institute | NCI Wiki  
Long NameStaging, Myeloma NCI Standard Template
DefinitionThe collection of CDEs used in the myeloma staging module.
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowRELEASED
TypeCRF
Public ID3461053
Version1.0
Module Long NameModule InstructionsQuestionCDECDE Public IDCDE VersionQuestion InstructionsValue Domain Data TypeValue Domain Unit of MeasureDisplay FormatValid ValueForm Value Meaning TextForm Value Meaning Desc.
Mandatory Myeloma Staging QuestionsThese items must be included when this data is collected for reporting.
Date Current Staging Assessment CompletedCurrent Stage Complete Assessment Date627393.0DATEMM/DD/YYYY
Conditional Myeloma Staging QuestionsThere are business rules to indicate situations under which this element should be used on a case report form.
Durie-Salmon StageMyeloma Diagnosis Stage21813631.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
I - ALL of the following must be presentI - ALL of the following must be present (hemoglobin >10 g/dL; serum calcium <12 mg/dL; urine light chains <4 g/24 hrs; normal bones on radiograph or solitary plasmacytoma; IgG <5 g/dL; IgA <3 g/dL)I - ALL of the following must be present (hemoglobin >10 g/dL; serum calcium <12 mg/dL; urine light chains <4 g/24 hrs; normal bones on radiograph or solitary plasmacytoma; IgG <5 g/dL; IgA <3 g/dL)
II - Fitting neither Stage I or Stage IIIII - fitting neither Stage I or Stage IIIII - fitting neither Stage I or Stage III
III - one of the following must be presentIII - one of the following must be present (hemoglobin <8.5 g/dL; serum calcium >12 mg/dL; urine light chains >12 g/24 hrs; advanced lytic bone lesions (>3 lytic lesions); IgG >7 g/dL; IgA >5 g/dL)III - one of the following must be present (hemoglobin <8.5 g/dL; serum calcium >12 mg/dL; urine light chains >12 g/24 hrs; advanced lytic bone lesions (>3 lytic lesions); IgG >7 g/dL; IgA >5 g/dL)
UnknownUnknownNot known, not observed, not recorded, or refused.
What was the International Staging System for Myeloma Stage?Plasma Cell Myeloma International Staging System for Myeloma Stage26892801.0Conditionality Rule: Inclusion based on patient population being studied.CHARACTER
Stage 1ISS Stage I Plasma Cell MyelomaPlasma cell myeloma with beta-2-microglobulin less than 3.5 and albumin greater than or equal to 3.5 (median survival of 62 months). Note that the older Durie/Salmon staging system defines stage I quite differently. (PDQ)
Stage 2ISS Stage II Plasma Cell MyelomaPlasma cell myeloma with beta-2-microglobulin less than 3.5 and albumin less than 3.5 or beta-2-microglobulin 3.5 to less than 5.5 (median survival of 44 months). Note that the older Durie/Salmon staging system defines stage II quite differently. (PDQ)
Stage 3ISS Stage III Plasma Cell MyelomaPlasma cell myeloma with beta-2-microglobulin greater than or equal to 5.5 (median survival of 29 months). Note that the older Durie/Salmon staging system defines stage III quite differently. (PDQ)
unknownUnknownNot known, not observed, not recorded, or refused.
Optional Myeloma Staging QuestionsThere is no requirement for inclusion of these elements on the case report form. If the design and scientific questions posed in the study dictate the need to collect this type of data, these elements should be included.
Staging Time PointDisease Staging Timepoint Name28473521.0CHARACTER
Current DiagnosisCurrent DiagnosisOccurring in or belonging to the present time.: The investigation, analysis and recognition of the presence and nature of disease, condition, or injury from expressed signs and symptoms; also, the scientific determination of any kind; the concise results of such an investigation.
Initial DiagnosisFirst DiagnosisPreceding all others in time or space or degree.: The investigation, analysis and recognition of the presence and nature of disease, condition, or injury from expressed signs and symptoms; also, the scientific determination of any kind; the concise results of such an investigation.
RestagingRestagingRepeat of staging assessment
Study EnrollmentClinical Study EnrollmentResearch conducted with human subjects or on material of human origin in which an investigator directly interacts with human subjects; includes development of new technologies, mechanism of human diseases, therapy, clinical trials, epidemiology, behavior and health services research. : Enrollment; to insert, register, or enter in a list, catalog, or roll. (Merriam-Webster Online)