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Multiple MyelomaPhase 3NCT00057564

A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma

A Phase 3 study testing A (Thalidomide + Dexamethasone) in people with Multiple Myeloma, run by Celgene Corporation at 99 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To compare the efficacy of combination oral thalidomide plus oral dexamethasone treatment to that of oral dexamethasone-alone treatments as induction (first-line) therapy for subjects with active multiple myeloma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
A (Thalidomide + Dexamethasone)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
470 participants
Where
99 sitesin 16 countries
Study dates
Feb 2003to Aug 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Active Multiple Myeloma Stage II or III Durie Salmon
  • Measurable levels of myeloma paraprotein in serum (≥1.0g/dL) or urine (≥ 0.2g excreted in a 24-hour collection sample)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
  • Women of child bearing potential must agree to abstain for heterosexual intercourse or use 2 methods of contraception, one effective (for example hormonal or tubal ligation) and one barrier (for example latex condom, diaphragm)
  • Males must agree to use barrier contraception (latex condoms) when engaging in reproductive activity

Who cannot join

  • Pregnant or lactating females
  • Peripheral neuropathy ≥ to grade 2 of the NCI CTC.
  • Prior history of malignancy unless subject has been free of disease for ≥ 3 years
  • Lab abnormality: Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1.0 x 10^9/L)
  • Lab abnormality: Platelet count <50,000/mm^3 (50.0 x 10^9/L)
  • Lab abnormality: Serum creatinine >3.0 mg/dL (265 µmol/L)
  • Lab abnormality: Serum glutamic oxaloacetic transaminase (SGOT) /Aspartate aminotransferase (AST) or Serum glutamic pyruvic transaminase (SGPT)/Alanine transaminase (ALT) >3.0 x upper limit of normal (ULN)
  • Lab abnormality: Serum total bilirubin > 2.0 mg/dL (34 µmol/L)

Trial locations and contacts

99 sites in 16 countries.

99 sites in 16 countries

United States26 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0922

  • Medical College of Georgia

    Augusta, Georgia, 30912-3125

  • Southern Illinois Hematology /Oncology

    Centralia, Illinois, 62801

  • Rush Cancer Institute Section of Hematology

    Chicago, Illinois, 60612-3824

  • Cleveland Clinic- Taussig Cancer Center

    Cleveland, Ohio, 44195

  • The Family Centre, PLLC

    Collierville, Tennessee, 38017

  • Hackensack University Hospital

    Hackensack, New Jersey, 07601

  • Clinical Research Consultants, Inc.

    Hoover, Alabama, 35216

  • University of Iowa Hospital of Clinic

    Iowa City, Iowa, 52242

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • East Tennessee Oncology/Hematology Associates

    Knoxville, Tennessee, 37920

  • UCLA School of Medicine

    Los Angeles, California, 90095

  • Melbourne Internal Medicine Associates Oncology

    Melbourne, Florida, 32901-3182

  • Jackson Memorial Hospital and Clinics

    Miami, Florida, 33136

  • University of Miami Miller School/Jackson Memorial Hospital

    Miami, Florida, 33136

  • University of Miami

    Miami, Florida, 33136

  • Oncology Hematology Group of South Florida

    Miami, Florida, 33176

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Ocshner Clinic Foundation

    New Orleans, Louisiana, 70121

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Arizona Clinical Research Center

    Tucson, Arizona, 85712

  • South Carolina Oncology Group

    West Columbia, South Carolina, 29169

  • James Berenson

    West Hollywood, California, 90069

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157-1023

Other trials in United States

Russia12 sites

  • Chelyabinsk Regional Clinical Hospital Hematology Dpt

    Chelyabinsk, 454076

  • Republican Clinical Hospital #1 Hematology Dpt.

    Izhevsk, 426039

  • Burdenko Central Military Clinical Hospital Hematology Center

    Moscow, 105229

  • Russian Academy of Medical Sciences Scientific Center of Hematology

    Moscow, 125167

  • Novosibirsk State Regional Clinical Hospital Hematology Centre

    Novosibirsk, 630087

  • Research Institute of Hematology and Blood Transfusion,Clinical Department of Hematology with Bone Marrow Transplantation Unit

    Saint Petersburg, 193024

  • St. Petersburg Pavlov State Medical University Bone Marrow Transplantation Clinic

    Saint Petersburg, 197022

  • Clinical Hospital #31 Dpt of Bone Marrow Transplantation and Chemotherapy of Patients with Myeloproliferative Disorders

    Saint Petersburg, 197110

  • Samara Regional Clinical Hospital Dep't. of Hematology and Bone Marrow Transplantation

    Samara, 443095

  • Blokhin Cancer Research Center Dpt of Myeloproliferative Disorders Chemotherapy

    Shosse, 115478

  • Nizhny Novgorod Clinical Hospital

    Velikiy Novgorod, 603126

  • Ekaterinburg 1st Regional Clinical Hospital Regional Hematology Centre

    Yekaterinburg, 620102

Other trials in Russia

Ukraine11 sites

  • Cherkassy Regional Oncology Center

    Cherkassy, 18009

  • Dnepropetrovsk City Clinical Hospital #4 Regional Hematology Centre

    Dnipro, 49044

  • Ivano-Frankovsk Regional Clinical Hospital - Hospital Therapy Department

    Ivano-Frankivsk, 76000

  • Kharkov Regional Clinical Oncology Center Dep't of Oncology and Pediatric Oncology

    Kharkiv, 61070

  • Kiev Institute of Oncology of the UAMS Systemic Malignancies Department

    Kiev, 03022

  • Kiev Bone Marrow Transplantation Center Bone Marrow Transplantation Department

    Kiev, 03115

  • Institute of Hematology and Transfusiology of the UAMS Department of Blood Diseases with Clinical Biochemistry Group

    Kiev, 04060

  • Institute of Blood Pathology and Transfusion Medicine of the UAMS

    Lviv, 79044

  • Odessa Regional Clinical Hospital Hematology Dep't

    Odesa, 65025

  • Zaporozhje Regional Clinical Hospital Hematology Dpt

    Zaporizhzhya, 69600

  • Zhitomir Regional Clinical Hospital Hematology Centre

    Zhytomyr, 10002

Other trials in Ukraine

Italy7 sites

  • Universita di Bari Dipartimento di Scienze Umana Sezione de Medicina Interna e Oncologia Medica Policlinico

    Bari, 11

  • Istituto di Ematologia e Oncologia Medica "L. e. A. Seragnoli"

    Bologna, 40138

  • Azienda Ospedaliera San Martino

    Genova, 16132

  • Ospedale Niguarda Ca Granda

    Milan, 20162

  • Policlinico San Matteo

    Pavia, 27100

  • Università La Sapienza Dipartimento di Biotecnologie Cellulari ed Ematologia

    Roma, 00161

  • Clinica Ematologica Policlinico Universitario

    Udine, 33100

Other trials in Italy

Australia6 sites

  • Frankston Hospital

    Frankston, Victoria, 3199

  • Royal Brisbane Hospital

    Herston, Queensland, 4029

  • Peter MacCallum Cancer Institute

    Melbourne, Victoria, 3002

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Bone Marrow Transplant Service Dept of Clinical Haematology and Medical Oncology

    Parkville, Victoria, 3050

  • Haematology Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada6 sites

  • Centre Hopitalier Universitaire de Sherbrooke Hospital Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • Dalhousie University

    Halifax, Nova Scotia, B3H2Y9

  • McGill University

    Montreal, Quebec, PQ H2W 1S6

  • Saskatoon Cancer Centre University of Saskatoon

    Saskatoon, Saskatchewan, S7N 4H4

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • University Health Network Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Poland6 sites

  • Medical Academy of Bialystok

    Bialystok, 15-276

  • Institute of Internal Diseases University of Medicine

    Gdansk, 80-211

  • Jagiellonian University Collegium Medicum Department of Hematology

    Krakow, 31-501

  • Medical University of Lodz

    Lodz, 93-509

  • Private Medical Practice Centre of Clinical Laboratory of Densitometry At 'Officers of Professors'

    Lublin, 20-022

  • Medical University of Warsaw Dep't of Hematology, Oncology and Internal Diseases

    Warsaw, 02-097

Other trials in Poland

Spain6 sites

  • Hospital Clinic

    Barcelona, 08036

  • Hospital Universitario de la Princessa

    Madrid, 28006

  • Hospital Doce de Octubre

    Madrid, 28041

  • Clinica Universitaria de Navarra

    Pamplona, 31080

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

Other trials in Spain

Israel4 sites

  • Hadassah University Hospital Hematology Dep't

    ‘En Kerem, Jerusalem, 91120

  • Rambam Medical Center Dep't. Of Hematology

    Haifa, 31096

  • Tel Aviv Sourasky Medical Center Hematology Institute

    Tel Aviv, 64239

  • Director of Hematology Division BMT and CBB The Chaim Sheba Medical Center

    Tel HaShomer, 52621

Other trials in Israel

Belgium3 sites

  • Institut Jules Bordet Dep't of Clinical Haematology

    Brussels, 1000

  • Dept. Of Haematology Academisch Ziekenhuis VUB

    Brussels, 1090

  • University Hospital Ghent Dep't of Haematology

    Ghent, 900

Other trials in Belgium

Bulgaria3 sites

  • UMHAT Alexandrovska

    Alexandrovska

  • National Center of Haematology and Transfusiology

    Sofia, 1756

  • Military Medical Academy

    Sofia

Other trials in Bulgaria

United Kingdom3 sites

  • Belfast City Hospital Haematology Dpt.

    Belfast, BT9 7AB

  • Guys Hospital

    London, SE1 9RT

  • Guys Hospital

    London, SE19RT

Other trials in United Kingdom

Hungary2 sites

  • St. Laszlo Hoszpital

    Budapest

  • Petz Aladar County Hospital

    Győr, 9002

Other trials in Hungary

Ireland2 sites

  • MidWestern Regional Hospital Haematology Dpt.

    Dooradoyle, Limerick

  • Hope Directorate Dep't. Haematology St. James's Hospital

    Dublin, 8

Other trials in Ireland

Germany1 site

  • Universitaetsklinikum Dusseldorf Klinik fuer Haematologie

    Düsseldorf

Other trials in Germany

Switzerland1 site

  • Universitatsspital Zurich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: A Multicenter, Randomized, Parallel-group , Double Blind, Placebo-controlled Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone as Induction Therapy for Previously Untreated Subjects With Multiple Myeloma

To compare the efficacy of combination oral thalidomide plus oral dexamethasone treatment to that of oral dexamethasone-alone treatments as induction (first-line) therapy for subjects with active multiple myeloma

Being tested
A (Thalidomide + Dexamethasone), B (Placebo + Dexamethasone)
Keywords
Newly Diagnosed Multiple Myeloma, Multiple Myeloma
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A (Thalidomide + Dexamethasone)Drug

    Also called Thalidomide

    Thalidomide 50mg/day + Dexamethasone 40mg

  • B (Placebo + Dexamethasone)Drug

    Also called Dexamethasone, placebo

    Placebo + Dexamethasone 40mg

Study groups in NCT00057564
Study groupRoleWhat they receive
A (Thalidomide & Dexamethasone)ExperimentalThalidomide 50mg/day + Dexamethasone 40mg
Receives: Drug: A (Thalidomide + Dexamethasone)
B (Dexamethasone and placebo)Placebo comparatorDexamethasone and placebo
Receives: Drug: B (Placebo + Dexamethasone)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to tumor progression (TTP)

    Time to tumor progression (TTP)

    Measured: Up to 3 years

Secondary outcomes (4)

  1. Number of patients who survived

    Number of patients who survived

    Measured: Up to 3 years

  2. Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone)

    Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone)

    Measured: Up to 3 years

  3. Myeloma response rate

    Myeloma response determination criteria developed by Bladé et al 1998

    Measured: Up to 3 years

  4. Number of participants with adverse events

    Number of participants with adverse events

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2003 (estimated)
  2. Study startFeb 2003
  3. Primary completionApr 2006
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
470 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00057564
Sponsor's protocol ID
THAL-MM-003
Status last verified
Sep 2015
First submitted
4 Apr 2003
Last updated
11 Sep 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Rajkumar SV, Rosinol L, Hussein M, Catalano J, Jedrzejczak W, Lucy L, Olesnyckyj M, Yu Z, Knight R, Zeldis JB, Blade J. Multicenter, randomized, double-blind, placebo-controlled study of thalidomide plus dexamethasone compared with dexamethasone as initial therapy for newly diagnosed multiple myeloma. J Clin Oncol. 2008 May 1;26(13):2171-7. doi: 10.1200/JCO.2007.14.1853. Epub 2008 Mar 24.

    PubMed 18362366

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing A (Thalidomide + Dexamethasone) in people with Multiple Myeloma, run by Celgene Corporation at 99 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, Russia, Ukraine, Italy, Australia and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to tumor progression (TTP) (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00057564, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2015.

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Clinical Trial NCT00057564 | AzTrials