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International, Multi-center, Prospective, Double Randomized, Open Phase III Study Evaluating Thalidomide/Dexamethasone Versus Melphalan/Prednisone as Induction Therapy and Thalidomide/Interferon-alpha Versus Interferon-alpha as Maintenance Therapy in Newly Diagnosed Patients With Multiple Myeloma


Phase 2/Phase 3
19 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

International, Multi-center, Prospective, Double Randomized, Open Phase III Study Evaluating Thalidomide/Dexamethasone Versus Melphalan/Prednisone as Induction Therapy and Thalidomide/Interferon-alpha Versus Interferon-alpha as Maintenance Therapy in Newly Diagnosed Patients With Multiple Myeloma


Inclusion Criteria:



- Patients with Multiple Myeloma of IgG, IgA, IgD, IgE, IgM lambda or kappa light
chain, low secretory or non-secretory disease

- WHO performance status 0,1,2,or 3

- No prior treatment of multiple myeloma

- Clear requirement of treatment (usually Durie/Salmon stage II or III)

- Anticipated life expectancy of at least 3 months

- Adequate organ function

- Minimum recovery period of 2 weeks following any major surgical procedure before
entry into this study

- Women, who are sterilized via hysterectomy or bilateral tubal ligation or at least
one year post-menopausal

- Age of at least 19 years, there is no upper age limit patients must have been
informed and must have signed an informed consent

Exclusion Criteria:

- Extramedullary plasmocytoma or solitary plasmocytoma without evidence of
dissemination of disease

- Benign monoclonal gammopathy

- Multiple myeloma of IgM without osteolytic bone lesions

- Smouldering myeloma

- More than 3 irradiation fields

- Irreversible performance status of WHO4

- Prior treatment of myeloma with any of the following: chemotherapeutic or
immunomodulatory agents, corticosteroids, antiangiogenic agents or other
investigational drugs

- Women of childbearing potential

- Preexisting peripheral polyneuropathy

- Congestive heart failure NYHA III, IV

- Acute infection requiring systemic antibiotics at study entry until resolved

- Any uncontrolled underlying medical condition (eg diabetes, glaucoma)

- Second primary malignancy (with the exception of cervical carcinoma in situ and
non-myeloma skin malignancies) unless patient has been disease-free for at least
three years

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression

Principal Investigator

Heinz Ludwig, MD,Univ.Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Austria: Federal Ministry for Health and Women

Study ID:

01-002-0601

NCT ID:

NCT00205751

Start Date:

August 2001

Completion Date:

October 2009

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • first line treatment
  • thalidomide
  • melphalan
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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