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A Phase 3 Study With Randomization to Melphalan/Prednisone/Thalidomide Versus Melphalan/Prednisone/Placebo to Patients With Previously Untreated Multiple Myeloma


Phase 3
N/A
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

A Phase 3 Study With Randomization to Melphalan/Prednisone/Thalidomide Versus Melphalan/Prednisone/Placebo to Patients With Previously Untreated Multiple Myeloma


Thalidomide has recently emerged as an effective treatment for patients with myeloma
refractory to conventional chemotherapy. So far only limited experience is available on
thalidomide for newly diagnosed myeloma. Therefore the Nordic Myeloma Study Group decided to
perform a trial comparing traditional melphalan-prednisone therapy with melphalan-prednisone
+ thalidomide/placebo. The study design is a multicentre double-blind randomised
placebo-controlled trial. Mainly patients >65 years of age will be included since patients
<65 years will be treated with high dose chemotherapy with autologous stem cell support. The
primary end-point is overall survival. Secondary end-points are quality of life, response
rate, time to response, response duration and toxicity.


Inclusion Criteria:



- Patients with multiple myeloma in need of treatment

Exclusion Criteria:

- Previous treatment against multiple myeloma

- Need of high dose chemotherapy with autologous stem cell support

- Women in fertile age

- Psychiatric disease or mental reduction leading to lack of cooperation

- Lack of consent

- Life expectancy below 3 months

- Active cancer of other etiology

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

october 2007

Safety Issue:

No

Principal Investigator

Anders Waage, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Haematology, St. Olavs hospital/NTNU, N-7006 Trondheim

Authority:

Norway: Norwegian Medicines Agency

Study ID:

NMSG #12

NCT ID:

NCT00218855

Start Date:

January 2002

Completion Date:

April 2007

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Phase 3, randomised, double blind study
  • thalidomide
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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