Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 78 of 107 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

Combination Chemotherapy With or Without Thalidomide in Treating Patients With Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00028886
Recruitment Status : Unknown
Verified October 2012 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 17, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 cancer. Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect). It is not yet known whether chemotherapy followed by peripheral blood stem cell transplant is more effective with or without thalidomide in treating multiple myeloma.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy with thalidomide to see how well it works compared with giving combination chemotherapy without thalidomide in treating patients with multiple myeloma.


Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Biological: filgrastim Biological: recombinant interferon alfa Drug: cyclophosphamide Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: melphalan Drug: thalidomide Drug: vincristine sulfate Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation Phase 3

Detailed Description:

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:

  • Patients receive induction chemotherapy (AD) comprising doxorubicin IV on days 1-4 and oral dexamethasone on days 1-4, 9-12, and 17-20. Patients receive oral thalidomide daily beginning on day 1 and continuing until 2 weeks before start of stem cell mobilization. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
  • Patients receive stem cell mobilization with chemotherapy comprising cyclophosphamide IV on day 1 and doxorubicin IV and oral dexamethasone on days 1-4 (CAD). Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until last apheresis.
  • Beginning 8-10 weeks after stem cell collection, patients receive low-dose oral thalidomide daily and high-dose melphalan IV on days -3 and -2 as intensification. Patients undergo stem cell infusion on day 0. Patients may receive a second course of high-dose melphalan 2-3 months after the first course, in which case, stem cell infusion follows the second course of melphalan.
  • Patients receive maintenance therapy with oral thalidomide daily until disease progression or after 3 months if no response.
  • Beginning 2 months after the last course, patients with an HLA-identical sibling donor undergo nonmyeloablative stem cell transplantation after radiotherapy.

Arm II:

  • Patients receive induction chemotherapy (VAD) comprising vincristine IV and doxorubicin IV on days 1-4 and dexamethasone on days 1-4, 9-12, and 17-20. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
  • Patients receive stem cell mobilization with CAD chemotherapy as in arm I. G-CSF is given as in arm I.
  • Patients receive high-dose melphalan and undergo stem cell infusion as in arm I.
  • Patients receive maintenance therapy with interferon alfa SC 3 times weekly until progression or after 3 months if no partial response.
  • Beginning 2 months after the last course, patients with an HLA-identical sibling donor undergo nonmyeloablative stem cell transplantation after radiotherapy.

All patients are followed every 6 months for 3 years and then annually thereafter.

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study On The Effect Of Thalidomide Combined With Adriamycin, Dexamethasone (AD) And High Dose Melphalan In Patients With Multiple Myeloma
Study Start Date : March 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Thalidomide




Primary Outcome Measures :
  1. Event-free survival

Secondary Outcome Measures :
  1. Partial response and complete response
  2. Overall survival
  3. Progression-free survival
  4. Toxicity


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • Patients 18 to 55 years of age must not have been allocated before study randomization to allogeneic stem cell transplantation with an HLA-identical sibling donor

Chemotherapy:

  • No more than 2 prior courses of melphalan and prednisone therapy for local myeloma progression
  • No other prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Prior local radiotherapy for local myeloma progression allowed
  • No other prior radiotherapy

Surgery:

  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00028886


Locations
Layout table for location information
Belgium
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Netherlands
HagaZiekenhuis - Locatie Leyenburg
's-Gravenhage, Netherlands, 2545 CH
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands, 5211 NL
Meander Medisch Centrum
Amersfoort, Netherlands, 3816 CP
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066 CX
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 1081HV
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, Netherlands, 1105 AZ
Medisch Spectrum Twente
Enschede, Netherlands, 7500 KA
University Medical Center Groningen
Groningen, Netherlands, 9713 EZ
Medisch Centrum Leeuwarden - Zuid
Leeuwarden, Netherlands, 8934 AD
Leiden University Medical Center
Leiden, Netherlands, 2300 RC
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6202 AZ
Sint Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435 CM
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, Netherlands, NL-6500 HB
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, Netherlands, 3008 AE
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Isala Klinieken - locatie Sophia
Zwolle, Netherlands, 8000 GK
Sponsors and Collaborators
Commissie Voor Klinisch Toegepast Onderzoek
Investigators
Layout table for investigator information
Study Chair: H. Lokhorst, MD, PhD UMC Utrecht

Publications of Results:
Lokhorst H, van der Holt B, Zweegman S, et al.: Final analysis of HOVON-50 randomized phase III study on the effect of thalidomide combined with adriamycine,dexamethasone (AD) and high dose melphalan (HDM) in patients with multiple myeloma (MM). [Abstract] Blood 112 (11): A-157, 2008.

Other Publications:
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00028886     History of Changes
Other Study ID Numbers: CDR0000069144
CKTO-2001-02
HOVON-50MM
EU-20133
HOVON-CKVO-2001-02
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: October 2012

Keywords provided by National Cancer Institute (NCI):
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Layout table for MeSH terms
Hemostatic Disorders
Doxorubicin
Liposomal doxorubicin
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Cyclophosphamide
Interferons
Vincristine
Melphalan
Thalidomide
BB 1101
Interferon-alpha
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents