Randomised phase III study in elderly patients with a multiple myeloma on the value of Thalidomide added to Melphalan plus Prednisone

ISRCTN	ISRCTN90692740
DOI	https://doi.org/10.1186/ISRCTN90692740
Protocol serial number	NTR232; Ho49
Sponsor	Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
Funders	The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (Netherlands), Dutch Haemato-oncology Association (Stichting Hemato-Oncologie voor Volwassenen Nederland [HOVON]) (Netherlands)

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 04/02/2011

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 P.W. Wijermans
Scientific

Haga Hospital, location Leyenburg Hospital
Department of Hematology
P.O. Box 40551
Den Haag
2504 LN
Netherlands

Phone	+31 (0)70 3592556
Email	p.wijermans@hagaziekenhuis.nl

Study information

Primary study design	Interventional
Study design	Multicentre randomised open label active controlled parallel trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	HOVON 49 MM
Study objectives	The outcome in arm B is better than in arm A.
Ethics approval(s)	METC Ziekenhuis Leyenburg on the 23rd April 2002 Ref: 02.012
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Thalidomide, melphalan, prednisone
Primary outcome measure(s)	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])
Key secondary outcome measure(s)	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)
Completion date	01/01/2007

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	420
Key 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
Key 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
Date of first enrolment	01/08/2002
Date of final enrolment	01/01/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Haga Hospital, location Leyenburg Hospital,

Den Haag
2504 LN
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2010		Yes	No
Results article	results	17/03/2011		Yes	No