Tandem High Dose Melphalan Versus Triple Intermediate Dose Melphalan and Stem Cell Transplantation in Induction Phase and Prednisolone/IFN Versus IFN in Maintenance Therapy

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. Identifier: NCT00205764
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 25, 2013
Information provided by:
Austrian Forum Against Cancer

Brief Summary:
This is an international,multicenter, prospective, open, double randomised and controlled phase III study to compare the therapeutic efficacy of tandem high dose Melphalan versus triple intermediate dose Melpahaln in newly-diagnosed myeloma patients

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Melphalan Phase 3

Detailed Description:

Patients will be enrolled into this protocol before start of Induction therapy which consists of 3 cycles or VAD with a 4 week interval followed by 1 cycle of IEV after which stem cell harvesting is performed. After stem cell harvesting is completed Patients will be randomised to one of the high dose therapy arms after response evaluation (Complete remission, Partial remission or stable disease). One group is receiving 2 Cycles of Melphalan 200mg/m² each followed by stem cell transplantation, the other group is receiving 3 Cycles of Melphalan 100mg/m² also followed by stem cell transplantation each time.

After completing high dose therapy patients will be randomised into Maintenance responding with CR, PR or SD. The maintenance therapy will be continued until relapse or progression of disease as defined by the response criteria.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised, Non-blind, Parallel Group Study to Compare Tandem High Dose Melphalan (200mg/m²) Versus Triple Intermediate Dose Melphalan (100mg/m²) and Stem Cell Transplantation in Induction Phase and Prednisolone/IFN Versus IFN in Maintenance Therapy in Newly Diagnosed Patients With Multiple Myeloma
Study Start Date : March 1999
Actual Study Completion Date : October 2009

Primary Outcome Measures :
  1. Time to treatment failure

Secondary Outcome Measures :
  1. Response rate
  2. Time to response
  3. Tolerance of treatment
  4. Quality of life
  5. Overall survival

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with newly diagnosed multiple myeloma of either IgG, IgG, IgD, IgE, IgM (but excluding Waldenstöm´s macroglobulinemia) lambda of kappa light chain, low-secretory, non-secretory disease or plasma cell leukemia
  • Performance status of 0, 1, 2, or 3
  • Patients not pre-treated with cytostatic drugs
  • Patients who clearly require treatment (usually Durie and Salmon stage II or III)
  • Patients in stage I who are symptomatic and/or show progression of their disease
  • Patients must have an anticipated life expectancy of at least 3 months
  • Patients must have adequate organ function
  • Patients must have had a minimum recovery period of 2 weeks following any major surgical procedure before entry into this study
  • Patients must be between 19 and 70 years of age, also it is understood that most of the patients above 65 will not be eligible because of poor performance status or multimorbidity
  • Women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment
  • Patients must have signed an informed consent

Exclusion Criteria:

  • Patients with more than 3 irradiation fields
  • Patients presenting initially with one of the following conditions:
  • Extramedullary plasmacytoma or solitary plasmacytoma
  • Monoclonal gammopathy of undetermined significance
  • Smouldering myeloma
  • Patients with an irreversible performance status of 4
  • Medical of psychiatric conditions that compromise the patient´s ability to give informed consent or complete the study
  • Patients with congestive heart failure, NYHA III, IV
  • Known HIV positivity
  • Known intolerance to any of the study drugs or components
  • Acute infection requiring systemic antibiotics at study entry until fully resolved
  • Patients with any underlying medical condition which cannot be adequately controlled
  • Patients with second primary malignancies (with the exception of cervical carcinoma in situ and non-melanoma skin malignancies) are not eligible unless the patient has been disease-free for at least five years

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 identifier (NCT number): NCT00205764

Wilhelminenspital, 1st Medical Department-center for oncology and hematology
Vienna, Austria, 1160
Sponsors and Collaborators
Austrian Forum Against Cancer
Principal Investigator: Heinz Ludwig, MD,Univ.Prof Wilhelminenspital 1st medical dep.-center for oncology and hematology Identifier: NCT00205764     History of Changes
Other Study ID Numbers: 03/99
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by Austrian Forum Against Cancer:
Multiple Myeloma
first line tretment
high dose chemotherapy
stem cell transplantation
maintenance therapy

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Methylprednisolone Hemisuccinate
Prednisolone acetate
Methylprednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs