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Thalidomide to Patients With Previously Untreated Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00218855
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : March 7, 2014
Sponsor:
Collaborators:
The Research Council of Norway
Nordic Myeloma Study Group, Germany
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Myeloma Drug: thalidomide Drug: placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 363 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2002
Primary Completion Date : April 2007
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Thalidomide
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. overall survival [ Time Frame: october 2007 ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: october 2007 ]
  2. Time to response [ Time Frame: october 2007 ]
  3. Frequency of response [ Time Frame: october 2007 ]
  4. Time to progression [ Time Frame: october 2007 ]
  5. Time to 2. response [ Time Frame: october 2007 ]
  6. Frequency of 2. response [ Time Frame: october 2007 ]
  7. Time to 2. progression [ Time Frame: october 2007 ]
  8. Toxicity [ Time Frame: october 2007 ]
  9. Time to definitive treatment failure [ Time Frame: october 2007 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00218855     History of Changes
Other Study ID Numbers: NMSG #12
NFR 90000288
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: March 7, 2014
Last Verified: March 2014

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
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents