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

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR321
• Date of registration: 09/09/2005
• Primary sponsor: VU University Medical Center, Dutch haemato-oncology association (Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
• Public title: Myelo-ablative chemo/radiotherapy and autologous stem cell transplantation as compared to only chemotherapy in patients with multiple myeloma.
• Scientific title: Myelo-ablative chemo/radiotherapy and autologous stem cell transplantation as compared to only chemotherapy in patients with multiple myeloma. - HOVON 24 MM
• Date of first enrolment: 7/11/1995
• Target sample size: 452
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=321
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: H.M. Lokhorst

• Name: H.M. Lokhorst

Key inclusion & exclusion criteria

Inclusion criteria: At entry:

1. Previously untreated multiple myeloma, stage 2 or 3 according to Salmon and Durie;

2. Age < 66 years;

3. WHO performance status 0-3;

4. Informed consent;




For IFN maintenance and PBSCT or ABMT:

5. At least PR after induction therapy;

6. WHO performance status 0-2;

7. Suitable peripheral stem or bone marrow graft;

8. No active infections;

9. Absence of severe cardiac, pulmonary, neurologic, psychiatric disease;

10. Serum creatinine, bilirubin and transaminases of less than 2.5x upper limit of normal values;

11. Platelet count > 50x10^9/l;

12. Absolute neutrophil count > 1x10^9/l;

13. Informed consent.
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).

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Multiple myeloma (Kahler's disease)

Intervention(s)

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 between:

Arm I:

PBSC pheresis after cyclophosphamide priming (cyclophosphamide, mesnum, G-CSF), IDM (melphalan, G-CSF) q 8 weeks 2 courses. In case of PR/CR maintenance therapy with IFN-alpha-2a until relapse. PBSCT may be performed after reinduction or relapse.

Arm II:

PBSC pheresis after cyclophosphamide priming (cyclophosphamide, mesnum, G-CSF), IDM (melphalan, G-CSF) q 8 weeks 2 courses. In case of PR/CR intensive treatment with cyclophosphamide/TBI and autologous transplantation, maintenance with IFN-alpha-2a until relapse.

Primary Outcome(s)

Remission rate.

Secondary Outcome(s)

1. Event-free survival;

2. Overall survival;

3. Quality of life;

4. Cost-benefit.

Secondary ID(s)

Ho24

ISRCTN82155239

Source(s) of Monetary Support

Amgen, CKTO, Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON), Johnson & Johnson, Roche Nederland BV, Novartis Pharma B.V.