|- candidate number||2617|
|- NTR Number||NTR987|
|- Date ISRCTN created||27-jun-2007|
|- date ISRCTN requested||11-jun-2007|
|- Date Registered NTR||4-jun-2007|
|- Secondary IDs||CCMO NL14746.078.07; Erasmus MC METC 2007-033 |
|- Public Title||Vertebroplasty versus radiotherapy as palliative treatment of vertebral metastases of multiple myeloma (M. Kahler)
|- Scientific Title||Vertebroplasty versus radiotherapy as palliative treatment of vertebral metastases of multiple myeloma (M. Kahler)
|- hypothesis||Vertebroplasty improves the quality of life of the individual patient by increased pain reduction and restoration of mobility. Vertebroplasty also reduces costs, as it decreases the number of inpatient days, the number of outpatient visits and follow-up treatments, and the need for home care.
|- Healt Condition(s) or Problem(s) studied||Multiple myeloma (Kahler's disease), Vertebroplasty, Spinal metastases|
|- Inclusion criteria||1. Persistent pain caused by vertebral metastases from myeloma (including plasmacytoma) with VAS score >4 (scale: 1-10);
2. Informed consent;
3. Older than 18 years;
|- Exclusion criteria||1. >4 affected vertebrae;
2. Vertebral fracture through back wall with retropulsion that consumes more than 33% of the spinal channel;
3. Myelum compression with neurological degeneration: Frankel A/B;
5. Incorrigible coagulopathy;
6. Karnofsky score <30 (moribund);
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||4-jun-2007|
|- planned closingdate||1-mrt-2010|
|- Target number of participants||104|
|- Interventions||Arm I (control):
radiotherapy (20 Gy) of affected vertebrae
vertebroplasty of affected vertebrae
|- Primary outcome||1. Degree of pain (VAS-pain score, scale: 0-10; pre-treatment and first 7 days post procedure);
2. Use of pain medication (pretreatment and day 0,day 7, week 4, week 12, month 6, year 1 after treatment)
|- Secondary outcome||1. Initial technical success & complications
Mobility (Oswestry-daily activity scale);
2. Quality of life (questionnaires:EORTC QLQ-MY24, SF-36);
3. Collapse of treated vertebrae (lateral X-WK)
5. Direct medical costs (e.g. procedure costs, hospitalisation days, pain medication, secondary interventions, revalidation or nursing home costs, follow-up)
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Research Office, Erasmus MC Dept of Radiology|
|- CONTACT for SCIENTIFIC QUERIES||Professor P.M.T. Pattynama|
|- Sponsor/Initiator ||Erasmus Medical Center, department of Radiology|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, department of Radiology|
|- Brief summary||Background:
As the current anti-tumor treatment extends the life of M. Kahler (multiple myeloma) patients, palliative treatment of the vertebral metastases is becoming more important as these frequently induce invalidating pain and cause patients to become bed-ridden. The standard treatment fo these metastases is radiotherapy, which reduces the pain in less than 50% of patients and which is often temporary even in the patients in which it works. Furthermore, radiotherapy is ineffective in stabilizing affected vertebrae.
The recently-introduced treatment Vertebroplasty appears more effective: in initial tests, vertebroplasty gave lengthy (permanent) pain reduction in 80-90% of the patients. As vertebroplasty also stabilizes the treated vertebrae, it gives additional benefits such as immediate recovery of mobility and long-term prevention of pathological disintegration of vertebrae and neurological degeneration.
Vertebroplasty is expected to improve the quality of life of the individual test subject by increased pain reduction and restoration of mobility. We also expect that vertebroplasty will reduce costs, in that we expect it will decrease the number of inpatient days, the number of outpatient visits and follow-up treatments, and the need for home care.
Compare vertebroplasty with radiotherapy regarding costs and effectivity in treating pain, restoring mobility, and improving quality of life.
Prospective clinical outcome study with randomization between 2 treatment arms (control = radiotherapy, expt = vertebroplasty). Blinding not possible due to the type of treatment.
Adult multiple myeloma patients with spinal metastases for which palliative treatment is indicated.
|- Main changes (audit trail)|
|- RECORD||4-jun-2007 - 3-jul-2007|