Contact information
Type
Scientific
Primary contact
Dr P.W. Wijermans
ORCID ID
Contact details
Haga Hospital
location Leyenburg Hospital
Department of Hematology
P.O. Box 40551
Den Haag
2504 LN
Netherlands
+31 (0)70 3592556
p.wijermans@hagaziekenhuis.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR232; Ho49
Study information
Scientific title
Acronym
HOVON 49 MM
Study hypothesis
The outcome in arm B is better than in arm A.
Ethics approval
METC Ziekenhuis Leyenburg on the 23rd April 2002
Ref: 02.012
Study design
Multicentre randomised open label active controlled parallel trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Multiple Myeloma
Intervention
Patients will be randomized on entry between:
Arm A: 8 cycles of Melphalan + Prednisone
Arm B: 8 cycles of Melphalan + Prednisone + Thalidomide
Non responders will be taken off protocol treatment after 3 cycles of therapy. If after 8 cycles a plateau-phase is reached therapy can be stopped. If after 8 cycles a patient still shows improvement of the disease, therapy will be continued until a plateau phase has been reached.
Thalidomide (50 mg/day) in arm B will be continued until disease progression.
Intervention type
Drug
Phase
Phase III
Drug names
Thalidomide, melphalan, prednisone
Primary outcome measures
1. Event free survival (i.e. time from registration to induction failure, death, progression or relapse whichever occurs first)
2. Response rate (complete response [CR] or partial response [PR])
Secondary outcome measures
1. Quality of life
2. Toxicity of the combination therapy
3. Overall survival measured from time of registration. Patients still alive or lost to follow up are censored at the date they were last known to be alive.
4. Progression free survival measured from the time of achievement of PR (or CR) to date of relapse, progression or death from any cause (whichever occurs first)
Overall trial start date
01/08/2002
Overall trial end date
01/01/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with a confirmed diagnosis of multiple myeloma stage Ib, II or III according to the Salmon & Durie criteria
2. Age >65 years
3. WHO performance status 0-3
4. Measurable tumorparameter (M-protein or Bence Jones proteïnuria)
5. Written informed consent
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
420
Participant exclusion criteria
1. Known intolerance to Thalidomide
2. Systemic AL amyloidosis
3. Polyneuropathy
4. Severe cardiac dysfunction (NYHA classification II-IV)
5. Severe pulmonary dysfunction
6. Significant hepatic dysfunction (serum bilirubin ≥30 mmol/l or transaminases ≥25 times normal level), unless related to myeloma
7. Renal failure with dependency on dialysis
8. Patients with active, uncontrolled infections
9. Pre-treatment with cytostatic drug or alpha interferon
10. Patients known to be HIV-positive
11. Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma
Recruitment start date
01/08/2002
Recruitment end date
01/01/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Haga Hospital, location Leyenburg Hospital,
Den Haag
2504 LN
Netherlands
Sponsor information
Organisation
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
Sponsor details
Vrije University Medical Centre (VUMC)
PO Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 2693
hdc@hovon.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Dutch Haemato-oncology Association (Stichting Hemato-Oncologie voor Volwassenen Nederland [HOVON]) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20516439
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21228328
Publication citations
-
Results
Wijermans P, Schaafsma M, Termorshuizen F, Ammerlaan R, Wittebol S, Sinnige H, Zweegman S, van Marwijk Kooy M, van der Griend R, Lokhorst H, Sonneveld P, , Phase III study of the value of thalidomide added to melphalan plus prednisone in elderly patients with newly diagnosed multiple myeloma: the HOVON 49 Study., J. Clin. Oncol., 2010, 28, 19, 3160-3166, doi: 10.1200/JCO.2009.26.1610.
-
Results
Gay F, Larocca A, Wijermans P, Cavallo F, Rossi D, Schaafsma R, Genuardi M, Romano A, Liberati AM, Siniscalchi A, Petrucci MT, Nozzoli C, Patriarca F, Offidani M, Ria R, Omedè P, Bruno B, Passera R, Musto P, Boccadoro M, Sonneveld P, Palumbo A, Complete response correlates with long-term progression-free and overall survival in elderly myeloma treated with novel agents: analysis of 1175 patients., Blood, 2011, 117, 11, 3025-3031, doi: 10.1182/blood-2010-09-307645.