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

Sponsored by:	Austrian Forum Against Cancer
Information provided by:	Austrian Forum Against Cancer
ClinicalTrials.gov Identifier:	NCT00205764

Purpose

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	Intervention	Phase
Multiple Myeloma	Drug: Melphalan	Phase III

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Melphalan Melphalan hydrochloride Sarcolysin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Austrian Forum Against Cancer:

Primary Outcome Measures:

Time to treatment failure

Secondary Outcome Measures:

Response rate
Time to response
Tolerance of treatment
Quality of life
Overall survival

Estimated Enrollment:	212
Study Start Date:	March 1999

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.

Eligibility

Ages Eligible for Study:	19 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205764

Contacts

Contact: Heinz Ludwig, MD,Univ.Prof

+43-1-49150 ext 2101

heinz.ludwig@wienkav.at

Locations

Austria
Wilhelminenspital, 1st Medical Department-center for oncology and hematology	Recruiting
Vienna, Austria, 1160
Contact: Heinz Ludwig, MD,Univ.Prof +43-1-49150 ext 2101 heinz.ludwig@wienkav.at
Principal Investigator: Heinz Ludwig, MD,Univ.Prof

Sponsors and Collaborators

Austrian Forum Against Cancer

Investigators

Principal Investigator:

Heinz Ludwig, MD,Univ.Prof

Wilhelminenspital 1st medical dep.-center for oncology and hematology

More Information

Study ID Numbers:	03/99
Study First Received:	September 12, 2005
Last Updated:	September 18, 2006
ClinicalTrials.gov Identifier:	NCT00205764
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Austrian Forum Against Cancer:

Multiple Myeloma
first line tretment
high dose chemotherapy
stem cell transplantation
maintenance therapy

Study placed in the following topic categories:

Melphalan
Immunoproliferative Disorders
Methylprednisolone
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Methylprednisolone acetate
Prednisolone acetate

Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Prednisolone
Lymphoproliferative Disorders
Methylprednisolone Hemisuccinate
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones

Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Cardiovascular Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009