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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Melphalan
Sponsored by
Austrian Forum Against Cancer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, first line tretment, high dose chemotherapy, stem cell transplantation, maintenance therapy

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wilhelminenspital, 1st Medical Department-center for oncology and hematology

Outcomes

Primary Outcome Measures

Time to treatment failure

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
November 21, 2013
Sponsor
Austrian Forum Against Cancer
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1. Study Identification

Unique Protocol Identification Number
NCT00205764
Brief Title
Tandem High Dose Melphalan Versus Triple Intermediate Dose Melphalan and Stem Cell Transplantation in Induction Phase and Prednisolone/IFN Versus IFN in Maintenance Therapy
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 Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Austrian Forum Against Cancer

4. Oversight

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, first line tretment, high dose chemotherapy, stem cell transplantation, maintenance therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Melphalan
Primary Outcome Measure Information:
Title
Time to treatment failure
Secondary Outcome Measure Information:
Title
Response rate
Title
Time to response
Title
Tolerance of treatment
Title
Quality of life
Title
Overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heinz Ludwig, MD,Univ.Prof
Organizational Affiliation
Wilhelminenspital 1st medical dep.-center for oncology and hematology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilhelminenspital, 1st Medical Department-center for oncology and hematology
City
Vienna
ZIP/Postal Code
1160
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

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