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

Austrian Forum Against Cancer

Status and phase

Completed

Phase 3

Conditions

Multiple Myeloma

Treatments

Drug: Melphalan

Study type

Interventional

Funder types

Other

Identifiers

NCT00205764

03/99

Details and patient eligibility

About

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

Full 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.

Enrollment

212 estimated patients

Sex

All

Ages

19 to 70 years old

Volunteers

No 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