Table II.
Clinical trials evaluating QoL in patients with MM undergoing ASCT
| ClinicalTrials.gov ID | Study Title | Outcome measures | QoL instrument used | Time points for QoL measurement |
|---|---|---|---|---|
| NCT02274519 | Novel Support Options in Autologous Stem Cell Transplant for Multiple Myeloma | Primary: Quality of life Secondary: Time to engraftment and febrile neutropenia |
NIH PROMIS Short form questionnaires for pain, depression, anxiety, social isolation, and sleep | Day 1, 14 and 30 of ASCT |
| NCT00600353 | Multi-day Doses in Prevention of Nausea and Emesis | Primary: Overall emetic response Secondary: Impact of nausea and vomiting on the QoL of patients undergoing ASCT |
Modified Osoba modules | Day 1, 3 and 7 of ASCT |
| NCT00747877 | High-Dose Melphalan and a Second Stem Cell Transplant or Low-Dose Cyclophosphamide in Treating Patients With Relapsed Multiple Myeloma After Chemotherapy | Primary: Time to disease progression Secondary: Response rate, overall survival, progression free survival, toxicity, safety and QoL |
EORTC QLQ-C30 and EORTC QLQ-MY20 questionnaires | Baseline and after completion of re-induction therapy |
| NCT03135925 | Feasibility of Pre Transplant Exercise (Pre-habilitation) for Multiple Myeloma Patients Awaiting Autologous Stem Cell Transplantation (PREeMPT) | Primary: Number of exercise sessions attended (feasibility) Secondary: Physical fitness and QoL |
FACT-MM (QoL1) and EORTC-QLQ-C30 MY20 (QoL2) | At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment |
| NCT03187223 | Bendamustine and Melphalan in Myeloma (BEB-2) | Primary: CR rate at 60 days after ASCT Secondary: Toxicity, engraftment, overall survival and QoL |
EORTC Q30 questionnaire | At screening and at day 60 post-ASCT |
| NCT01487031 | Music Therapy on Nausea and Pain for Autologous Stem Cell Transplantation | Primary: Patient perception of nausea and pain Secondary: QoL, narcotic medication use, monitoring of psychological responsiveness |
FACT-G7 | 7 days after intervention |
| NCT01811862 | Acupuncture for symptom control in hematopoietic stem cell transplantation patients | Primary: Area-under-curve for MDASI total score | MDASI | Day-2 to Day5 of ASCT |
Abbreviations: QoL: Quality of Life; MM: Multiple Myeloma; ASCT: Autologous Stem Cell Transplantation; PROMIS: Patient-Reported Outcomes Measurement Information System; FACT-G7: Functional Assessment of Cancer Therapy-General-7; EORTC: European Organization for Research and Treatment of Cancer; QLQ: Quality of Life Questionnaire;