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

November 21, 2013 updated by: Austrian Forum Against Cancer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

212

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1160
        • Wilhelminenspital, 1st Medical Department-center for oncology and hematology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to treatment failure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Austrian Forum Against Cancer

Investigators

  • Principal Investigator: Heinz Ludwig, MD,Univ.Prof, Wilhelminenspital 1st medical dep.-center for oncology and hematology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1999

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 21, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03/99

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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