Myelo-ablative chemo/radiotherapy and autologous stem cell transplantation as compared to only chemotherapy in patients with multiple myeloma
| ISRCTN | ISRCTN82155239 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82155239 |
| Secondary identifying numbers | Ho24 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 09/11/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr H.M. Lokhorst
Scientific
Scientific
University Medical Center Utrecht
Department of Hematology
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 2507230 |
|---|---|
| h.lokhorst@digd.azu.nl |
Study information
| Study design | Multicentre, randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | HOVON 24 MM |
| Study objectives | The hypothesis to be tested is that the outcome in arm II (and Allogeneic Bone Marrow Transplant [ABMT]) is better than in arm I. Objectives: 1. Evaluation of the effect of myeloablative chemo-/radiotherapy and autologous stem cell transplantation in comparison with chemotherapy alone with respect to the mentioned endpoints 2. Assessment of the value of risk factors at diagnosis with dose intensity of treatment |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Multiple Myeloma |
| Intervention | Patients will be treated with 3 x VAD (vincristine, doxorubicine, dexamethasone). Patients less than or equal to 55 years with a Human Leukocyte Antigen (HLA) identical sibling will proceed to Allo BMT. All other eligible patients will be randomised between: 1. Arm I: PBSC pheresis after cyclophosphamide priming (cyclophosphamide, mesnum, G-CSF), IDM (melphalan, G-CSF) every 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 2. 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 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Vincristine, doxorubicine, dexamethasone (VAD), cyclophosphamide, mesnum, Granulocyte Colony Stimulating Factor (G-CSF), melphalan |
| Primary outcome measure | Remission rate. |
| Secondary outcome measures | 1. Event-free survival 2. Overall survival 3. Quality of life 4. Cost-benefit |
| Overall study start date | 07/11/1995 |
| Completion date | 01/04/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 452 |
| Key inclusion criteria | At entry: 1. Previously untreated multiple myeloma, stage 2 or 3 according to Salmon and Durie 2. Aged less than 66 years 3. World Health Organization (WHO) performance status 0 - 3 4. Informed consent For Interferon (IFN) maintenance and Peripheral Blood Stem Cell Transplant (PBSCT) or Allogeneic Bone Marrow Transplant (ABMT): 1. At least Partial Remission (PR) after induction therapy 2. WHO performance status 0 - 2 3. Suitable peripheral stem or bone marrow graft 4. No active infections 5. Absence of severe cardiac, pulmonary, neurologic, psychiatric disease 6. Serum creatinine, bilirubin and transaminases of less than 2.5 x upper limit of normal values 7. Platelet count greater than 50 x 10^9/l 8. Absolute neutrophil count greater than 1 x 10^9/l 9. Informed consent |
| Key exclusion criteria | At entry: 1. Received more than 2 courses of melphalan, prednisone or vincristine, melphalan (M), cyclophosphamide, prednisone (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 greater than or equal to 25 x 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) |
| Date of first enrolment | 07/11/1995 |
| Date of final enrolment | 01/04/2000 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht,
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Sponsor information
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
Research organisation
Research organisation
Vrije University Medical Centre (VUMC)
PO Box 7057
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)20 444 2693 |
|---|---|
| hdc@hovon.nl | |
| Website | http://www.hovon.nl/ |
"ROR" |
https://ror.org/056kpdx27 |
Funders
Funder type
Industry
Roche Nederland B.V. (The Netherlands)
No information available
Amgen (The Netherlands)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Amgen Inc., Applied Molecular Genetics Inc.
- Location
- United States of America
Johnson & Johnson (The Netherlands)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Johnson & Johnson, johnson & Johnson Services, Inc., Johnson&Johnson, 强生公司, Johnson & Johnson Private Limited, ジョンソン・エンド・ジョンソント, J&J, JNJ
- Location
- United States of America
Commission for Medical Applied Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (The Netherlands)
No information available
Novartis Pharma B.V. (The Netherlands)
No information available
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | 15/03/2003 | Yes | No | ||
| Results article | 01/05/2003 | Yes | No | ||
| Other publications | 01/05/2004 | Yes | No |
