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Thalidomide to Patients With Previously Untreated Multiple Myeloma

This study has been completed.
Sponsor:
Collaborators:
The Research Council of Norway
Nordic Myeloma Study Group, Germany
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00218855
First received: September 20, 2005
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to test the effect of thalidomide in patients with multiple myeloma. The patients receive either thalidomide or a placebo tablet (neither patient nor doctor know which of these are given) in addition to the ordinary chemotherapeutic drug against multiple myeloma. We will find out for how long time the patients will stay free of the disease and for how long time they will live, and can evaluate whether thalidomide is a beneficial drug against this disease.


Condition Intervention Phase
Multiple Myeloma
Drug: thalidomide
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Study With Randomization to Melphalan/Prednisone/Thalidomide Versus Melphalan/Prednisone/Placebo to Patients With Previously Untreated Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • overall survival [ Time Frame: october 2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: october 2007 ] [ Designated as safety issue: No ]
  • Time to response [ Time Frame: october 2007 ] [ Designated as safety issue: No ]
  • Frequency of response [ Time Frame: october 2007 ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: october 2007 ] [ Designated as safety issue: No ]
  • Time to 2. response [ Time Frame: october 2007 ] [ Designated as safety issue: No ]
  • Frequency of 2. response [ Time Frame: october 2007 ] [ Designated as safety issue: No ]
  • Time to 2. progression [ Time Frame: october 2007 ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: october 2007 ] [ Designated as safety issue: No ]
  • Time to definitive treatment failure [ Time Frame: october 2007 ] [ Designated as safety issue: No ]

Enrollment: 363
Study Start Date: January 2002
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A Drug: thalidomide
tablets thalidomide start 100 mg x 2 escalating to 200 mg x 2 until plateau phase. Maintenance 100 mg x 2 until relapse. The same procedure is repeated by first relapse.
Other Name: thalidomide, Talix
Drug: placebo
100 mg x 2 mg tablets escalating to 200 mg x 2 until plateau phase. Maintenance 100 mg x 2 until relapse. This procedure is repeated by first relapse.
Other Name: no other names
Active Comparator: B Drug: thalidomide
tablets thalidomide start 100 mg x 2 escalating to 200 mg x 2 until plateau phase. Maintenance 100 mg x 2 until relapse. The same procedure is repeated by first relapse.
Other Name: thalidomide, Talix
Drug: placebo
100 mg x 2 mg tablets escalating to 200 mg x 2 until plateau phase. Maintenance 100 mg x 2 until relapse. This procedure is repeated by first relapse.
Other Name: no other names

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218855

Locations
Norway
Department of Haematology, St. Olavs hospital/NTNU
Trondheim, Norway, N-7006
Sponsors and Collaborators
Norwegian University of Science and Technology
The Research Council of Norway
Nordic Myeloma Study Group, Germany
Investigators
Study Chair: Anders Waage, MD Department of Haematology, St. Olavs hospital/NTNU, N-7006 Trondheim
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00218855     History of Changes
Other Study ID Numbers: NMSG #12, NFR 90000288
Study First Received: September 20, 2005
Last Updated: March 6, 2014
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Norwegian University of Science and Technology:
Multiple Myeloma
Phase 3, randomised, double blind study
thalidomide

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014