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Myelo-ablative chemo/radiotherapy and autologous stem cell transplantation as compared to only chemotherapy in patients with multiple myeloma.

Myelo-ablative chemo/radiotherapy and autologous stem cell transplantation as compared to only chemotherapy in patients with multiple myeloma.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20547
Enrollment
452
Registered
2005-09-09
Start date
1995-11-07
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple myeloma.

Interventions

Patients will be treated with 3x VAD (vincristine, doxorubicine, dexamethasone). Patients <=55 yrs with a HLA identical sibling will proceed to Allo BMTAll other eligible patients will be randomized b

Sponsors

Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data Center Erasmus MC - Daniel den Hoed Postbus 5201 3008 AE Rotterdam Tel: 010 4391568 Fax: 010 4391028 e-mail: hdc@erasmusmc.nl
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: At entry: 1. Previously untreated multiple myeloma, stage 2 or 3 according to Salmon and Durie; 2. Age 50x10^9/l; 12. Absolute neutrophil count > 1x10^9/l; 13. Informed consent.

Exclusion criteria

Exclusion criteria: At entry: 1. Received more than 2 courses of melphalan, prednisone or VMCP; 2. Severe cardiac disease (= severe heart failure requiring symptomatic treatment or a cardiac ejection fraction of less than 45% with presence of normal hemoglobin), severe pulmonary, neurologic or metabolic disease- Inadequate liver function, i.e. bilirubin >=2.5x upper normal value; 3. Prior malignancies except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma; 4. Prior extensive radiotherapy involving the myelum (precluding total body irradiation).

Design outcomes

Primary

MeasureTime frame
Remission rate.

Secondary

MeasureTime frame
1. Event-free survival; 2. Overall survival; 3. Quality of life; 4. Cost-benefit.

Contacts

Public ContactH.M. Lokhorst

University Medical Center Utrecht (UMCU), Department of Hematology (B02.226), P.O. Box 85500

h.lokhorst@umcutrecht.nl+31 (0)88 7557230

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)