Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
04/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.hovon.nl/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes