Table 4. . Patient/outcome assessments and schedule.

Parameter	Timing	Assessment	Prospective versus retrospective
Patient demographics	Baseline	– Age – Sex – Race – Ethnicity – Height – Weight – Insurance information – Geographic region	Prospective
Medical history at diagnosis	Baseline	– Date of initial diagnosis (month/year for RRMM; day/month/year for NDMM) and criteria used (ISS, R-ISS) – Stage (ISS or R-ISS) – Cytogenetics/FISH risk† – CRAB symptoms – Hematology: white blood cell count, absolute neutrophil count, hemoglobin, platelet count – Chemistry: calcium, creatinine, alkaline phosphatase, total bilirubin, aspartate aminotransferase, alanine aminotransferase, LDH, albumin, serum β2-microglobulin and BUN‡ – SPEP, serum FLC† and UPEP† – Imaging§ – History of MGUS/SMM – Frailty status: CCI, Katz Index of Independence in activities of daily living and Lawton instrumental activities of daily living scale – ECOG performance status	NDMM patients: prospective RRMM patients: retrospective
Medical history prior to study inclusion	Baseline	– Bone marrow – FLC† – M-component, immunofixation – Imaging§ – GEP† – Prodromal/other plasma cell disorders (MGUS, SMM, amyloidosis) – Plasmacytoma and extramedullary disease – Central nervous system involvement – Stem cell transplant – Vaccination	NDMM patients: prospective RRMM patients: retrospective
Medical evaluation	Baseline	– CCI – PN – Pneumococcal vaccine – Influenza A/B – Hypertension requiring treatment – Thromboembolism – Cardiac left ventricular function – Arrhythmias/pace-maker/AICD – Osteopenia/osteoporosis – Osteonecrosis of the jaw – Cataracts – MDS – MM-related radiation therapy – Orthopedic procedure/surgery for MM-related skeletal event – Other surgery/procedures	Prospective
	Quarterly	– PN – Amyloidosis – Pneumonia – Herpes zoster infection – Hypertension – Thromboembolism – Cataracts – Osteonecrosis of the jaw – Skeletal-related events – Cardiac events	Prospective
	Yearly	– Height and weight – Vaccinations – MDS – Secondary primary malignancy – Frailty status: CCI, Katz Index of Independence in activities of daily living and Lawton instrumental activities of daily living scale – ECOG performance status	Prospective
Prior therapies (RRMM)	Baseline	– RRMM: number of relapses and previous lines of therapy, regimens used in each line, prior SCT or consolidation/maintenance therapy, use of investigational therapy as part of a clinical trial, response, MRD†	Retrospective
Disease management	Baseline and quarterly	– Current therapy: type of regimens and drugs (including duration of treatment, sequencing of therapies, retreatment and use of continuous versus fixed-duration therapy), factors associated with treatment initiation, reasons for not receiving therapy, response and MRD for each regimen†, SCT, supportive care	Prospective
	Quarterly	– Changes or modifications to treatment: drug, schedule, dose, line of therapy and reasons for these changes – Hematology and chemistry, safety, MM-related radiation therapy and surgeries/procedures	Prospective
Effectiveness of treatment	Quarterly	– Bone marrow evaluation – FISH and/or cytogenetics† – MRD† – Imaging§ – NGS and GEP† – SPEP, serum FLC† and UPEP† – Response per IMWG criteria [31] – Progression status for each regimen – Date and cause of death	Prospective
PROs	Baseline and quarterly	– EORTC QLQ-C30: two items on Global Health Status/QoL subscale – EORTC QLQ-MY-20: single item on peripheral neuropathy – TSQM-9: effectiveness, convenience and global satisfaction domains	Prospective
HRU	Quarterly	– Inpatient and intensive care admissions – Reasons for admission and length of stay – Outpatient clinic visits – Emergency room visits	Prospective
Safety¶	Baseline and quarterly	– AEs and SAEs leading to treatment discontinuation (temporary and permanent) or drug modification – Frequency of secondary primary malignancy	Prospective

^†Assessment was performed if the test was available and carried out as part of routine practice at the study sites.

^‡If available.

^§Includes assessment of evidence of plasmacytoma, extramedullary disease, and diffuse involvement.

^¶Based on the latest version the National Cancer Institute the Common Terminology Criteria for Adverse Events.

AE: Adverse event; AICD: Automatic implantable cardioverter-defibrillator; BUN: Blood urea nitrogen; CCI: Charlson comorbidity index; CRAB: hyperCalcemia, Renal insufficiency, Anemia, Bone lesions; ECOG: Eastern Cooperative Oncology Group; EORTC: European Organization for Research and Treatment of Cancer; FISH: Fluorescence in situ hybridization; FLC: Free light chain; GEP: Gene expression profiling; HRU: Healthcare resource utilization; IMWG: International Myeloma Working Group; ISS: International Staging System; LDH: Lactate dehydrogenase; MDS: Myelodysplastic syndrome; MGUS: Monoclonal gammopathy of undetermined significance; MM: Multiple myeloma; MRD: Minimal residual disease; NDMM: Newly diagnosed multiple myeloma; NGS: Next-generation sequencing; PN: Peripheral neuropathy; PRO: Patient self-reported outcomes; QLQ-C30: Quality of Life Questionnaire – Core 30 Module; QLQ-MY-20: Quality of Life Questionnaire – 20-item Multiple Myeloma Module; QoL: Quality of life; R-ISS: Revised International Staging System; RRMM: Relapsed/refractory multiple myeloma; SAE: Serious adverse event; SCT: Stem cell transplant; SMM: Smoldering multiple myeloma; SPEP: Serum protein electrophoresis; TSQM-9: 9-Item Treatment Satisfaction Questionnaire for Medication; UPEP: Urine protein electrophoresis.