Know Cancer

or
forgot password

Thalidomide-Dexamethasone Incorporated Into Double Autologous Stem-Cell Transplantation for Patients Less Than 65 Years of Age With Newly Diagnosed Multiple Myeloma


Phase 2
18 Years
65 Years
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

Thalidomide-Dexamethasone Incorporated Into Double Autologous Stem-Cell Transplantation for Patients Less Than 65 Years of Age With Newly Diagnosed Multiple Myeloma

Inclusion Criteria


Inclusion criteria:

- Confirmed diagnosis of symptomatic MM based on standard criteria.

- No prior or current systemic therapy for MM, with exception of steroids.

- At least 18 years and less than 65 years of age.

- Presence of quantifiable M protein in serum or urine.

- Durie & Salmon stage II-III or I with disease progression.

- Adequate organ function (heart, lung).

- No previous deep vein thrombosis and/or recurring thrombophlebitis and/or pulmonary
embolisms, confirmed by doppler ultrasound or computed tomography scan.

- Willing and able to comply with the protocol requirements.

Exclusion criteria:

- Diagnosis of smouldering or asymptomatic MM, plasmacell leukemia, solitary
plasmocytoma of the bone o extramedullary plasmocytoma.

- Diagnosis of non-secretory MM.

- Prior or current systemic therapy for MM, with exception of steroids.

- More than 65 years of age.

- Female subjects pregnant.

- Non adequate organ function (heart, lung).

- Patient has a prior history of thrombosis or venous thromboembolism or pulmonary
embolism.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (at least PR, VGPR, nCR and CR) to thal-dex induction

Outcome Description:

Responses are reported by study investigators and centrally reassessed by study coordinator(s). Criteria are those initially proposed by the European Group for Blood and Marrow Transplantation (EBMT), with the addition of nCR (100% M-protein reduction by electrophoresis, but immunofixation-positive)and VGPR (at least 90% reduction of M component).

Outcome Time Frame:

120 days after the start day of tal-dex induction therapy

Safety Issue:

No

Principal Investigator

Michele Cavo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Authority:

Italy: Ethics Committee

Study ID:

MM-BO2002

NCT ID:

NCT01341262

Start Date:

March 2002

Completion Date:

January 2009

Related Keywords:

  • Multiple Myeloma
  • autologous stem cell transplantation
  • thalidomide
  • induction therapy
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location