Clinical Trial: Combination Chemotherapy With or Without Thalidomide in Treating Patients With Multiple Myeloma

This study is currently recruiting patients.

Sponsored by: Commissie Voor Klinisch Toegepast Onderzoek
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. It is not yet known if combination chemotherapy is more effective with or without thalidomide in treating multiple myeloma.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without thalidomide in treating patients who have multiple myeloma.

Condition Treatment or Intervention Phase
stage II multiple myeloma
stage III multiple myeloma
 Drug: cyclophosphamide
 Drug: dexamethasone
 Drug: doxorubicin
 Drug: filgrastim
 Drug: interferon alfa
 Drug: melphalan
 Drug: thalidomide
 Drug: vincristine
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: growth factor antagonist therapy
 Procedure: high-dose chemotherapy
 Procedure: interferon therapy
 Procedure: peripheral blood stem cell transplantation
Phase III

MedlinePlus related topics:  Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Doxorubicin, Dexamethasone, and High-Dose Melphalan With or Without Thalidomide in Patients With Multiple Myeloma

Further Study Details: 

OBJECTIVES:

  • Compare the efficacy of doxorubicin, dexamethasone, and high-dose melphalan with versus without thalidomide, in terms of event-free survival, of patients with multiple myeloma.
  • Determine the response rate, complete response rate, overall survival, and progression-free survival of patients treated with these regimens.
  • Determine the safety and toxicity of thalidomide in combination with intensive chemotherapy in these patients.
  • Assess the value of prognostic factors at diagnosis in individual patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and treatment policy (1 course vs 2 courses of high-dose melphalan). Patients are randomized to 1 of 2 treatment arms.

Arm I:

Arm II:

PROJECTED ACCRUAL: A total of 450 patients (225 per treatment arm) will be accrued for this study within 4 years.

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed multiple myeloma
  • Stage II or III
  • No systemic amyloid light-chain amyloidosis

PATIENT CHARACTERISTICS: Age:

  • 18 to 65

Performance status:

  • WHO 0-3

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • No significant hepatic dysfunction*
  • Bilirubin less than 1.75 mg/dL*
  • AST/ALT less than 2.5 times normal* NOTE: *Unless related to myeloma

Renal:

  • Not specified

Cardiovascular:

  • No severe cardiac dysfunction
  • No New York Heart Association class II, III, or IV heart disease

Other:

  • HIV negative
  • No active uncontrolled infection
  • No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
  • No known intolerance to thalidomide
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

Chemotherapy:

Endocrine therapy:

  • Not specified

Radiotherapy:

Surgery:

  • Not specified

Location and Contact Information


Belgium
      U.Z. Gasthuisberg, Leuven,  B-3000,  Belgium; Recruiting
G.E.G. Verhoef, MD, PhD  32-16-34608    gregor.verhoef@uz.kuleuven.ac.be 

Netherlands
      Academisch Medisch Centrum, Amsterdam,  1105 AZ,  Netherlands; Recruiting
M.H.J. Van Oers, MD  31-20-566-5785    m.H.vanoers@amc.uva.nl 

      Academisch Ziekenhuis Maastricht, Maastricht,  6202 AZ,  Netherlands; Recruiting
G.M.J. BOS, MD, PhD  31-43-387-7025    gbos@sint.a.zm.nl 

      Daniel Den Hoed Cancer Center at Erasmus Medical Center, Rotterdam,  3008 AE,  Netherlands; Recruiting
J.J. Cornelissen, MD  10-4391367 

      Isala Klinieken - locatie Sophia, Zwolle,  8000 GK,  Netherlands; Recruiting
Marinus Van Marwijk Kooij, MD  31-38-424-7039 

      Jeroen Bosch Ziekenhuis, 's-Hertogenbosch,  5211 NL,  Netherlands; Recruiting
H. A.M. Sinnige, MD  31 73 6162452 

      Leiden University Medical Center, Leiden,  2300 CA,  Netherlands; Recruiting
C.M. Segeren, MD  31-71-526-9111 

      Leyenburg Ziekenhuis, S. Gravenhage,  2545 CH,  Netherlands; Recruiting
Pierre W. Wijermans, MD, PhD  31-070-359-2556    hematologie@leyenburg-ziekenbuis.nl 

      Meander Medisch Centrum, Amersfoort,  3816 CP,  Netherlands; Recruiting
S. Wittebol, MD  00-31-33-4222345 

      Medisch Centrum Leeuwarden - Zuid, Leeuwarden,  8934 AD,  Netherlands; Recruiting
P. Joosten, MD  31-58-286-6965 

      Medisch Spectrum Twente, ENSCHEDE,  7500 KA,  Netherlands; Recruiting
M.R. Schaafsma, MD  31-53-487-2444 

      Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam,  1066 CX,  Netherlands; Recruiting
J. W. Baars, MD, PhD  31-20-512-2570 or 512-2568 

      Sint Antonius Ziekenhuis, Nieuwegein,  3435 CM,  Netherlands; Recruiting
O de Weerdt, MD  31-30-609-2052    o.weerdt@antonius.net 

      University Medical Center Groningen, Groningen,  9713 EZ,  Netherlands; Recruiting
Edo Vellenga, MD  31-50-361-2317    e.vellenga@jmt.azg.nl 

      University Medical Center Nijmegen, Nijmegen,  NL-6500 HB,  Netherlands; Recruiting
A.J. Croockewit, MD  31-24-361-1111 

      University Medical Center Utrecht, Utrecht,  3584 CX,  Netherlands; Recruiting
H. Lokhorst, MD, PhD  31-30-250-7230    h.lokhorst@azu.nl 

      Vrije Universiteit Medisch Centrum, Amsterdam,  1081HV,  Netherlands; Recruiting
P.C. Huijgens, MD, PhD  31-20-444-2604    hamatol@vumc.nl 

Study chairs or principal investigators

H. Lokhorst, MD, PhD,  Study Chair,  University Medical Center Utrecht   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000069144; CKVO-2001-02; HOVON-50MM; EU-20133; HOVON-CKVO-2001-02; NCT00028886
Record last reviewed:  September 2003
Last Updated:  April 4, 2005
Record first received:  January 4, 2002
ClinicalTrials.gov Identifier:  NCT00028886
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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