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Multiple MyelomaPhase 3OPTIMUMNCT00452569

Efficacy and Safety Study of 3 Thalidomide Doses for the Treatment of Relapsed Refractory Multiple Myeloma

A Phase 3 study testing Thalidomide and Dexamethasone in people with Multiple Myeloma, run by Celgene at 86 sites in 15 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

The primary objective is to compare the time to progression (TTP) of three daily doses of thalidomide (100, 200 and 400 mg) with high-dose dexamethasone in relapsed refractory multiple myeloma (MM) patients and to subsequently select the optimum thalidomide dose in terms of median TPP and toxicity. 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?
Thalidomide and Dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
499 participants
Where
86 sitesin 15 countries
Study dates
1 Feb 2006to 1 Jan 2009
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

  • Male or female patients, aged ≥ 18 years at the time of signing the informed consent form
  • Patients who have been previously diagnosed with MM who have received between 1 \& 3 prior lines of treatment for their disease, and who require therapy because of disease progression
  • Secretory MM with measurable levels of monoclonal protein in serum (> 10 g/L of IgG M-protein or > 5 g/L of IgA M-protein) or urine (≥ 200 mg/ 24hours); Patient with the following rare subclasses of the immunoglobulin: IgD, IgE, IgM can be included in the study if the level of monoclonal protein in serum is > 5g/L or ≥ 200 mg/24hours in urine. As IgM immunoglobulin isotype can be related to Waldenstrom's macroglobulinemia, it is important to distinguish and not include in the study patients with Waldenstrom's macroglobulinemia.
  • ECOG performance status of 0, 1, or 2
  • Life expectancy >3months
  • Able to adhere to the study visit schedule \& other protocol requirements
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  • Women of child-bearing potential must agree to use 2 methods of contraception for at least 4weeks before starting the therapy, during the Treatment Period, \& for 4 weeks after the last dose
  • Males must agree to use barrier contraception (latex condoms) when engaging in reproductive activity during the Treatment Period \& for 4 weeks after the last dose
  • Written, informed consent

Who cannot join

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the Informed Consent Form
  • Pregnant or lactating women. A serum β-hCG pregnancy test must be performed at the Screening visit for female patients of child-bearing potential. If the test is positive, the patient must be excluded from the study. Confirmation that the patient is not pregnant must be established by a negative serum or urinary pregnancy test with the result obtained 1day prior to the Baseline visit (or the day of the visit if results are available before drug delivery). A pregnancy test is not required for naturally post-menopausal women (who have not had menses at any time in the preceding 24 consecutive months) or surgically sterilized women (hysterectomy, bilateral ovariectomy, bilateral salpingectomy)
  • Non-secretory MM
  • Any of the following laboratory abnormalities: Absolute neutrophil count (ANC) <500 cells/mm3 (0.5 x 109/L); Platelet count <30,000/mm3 (30.0 x 109L) without transfusion support within 7 days before the test; Serum creatinine >3.0mg/dL (265μmol/L); Serum aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) >3.0 x upper limit of normal (ULN); Serum total bilirubin >2.0mg/dL (34μmol/L)
  • Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if s/he were to participate in the study, or which confounds the ability to interpret data from the study
  • Severe cardiac dysfunction (according to the New York Heart Association [NYHA] classification III-IV)
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  • Severe bradycardia (<50bpm)
  • Peripheral neuropathy ≥Grade 2 in severity (according to the NCI CTC Version 3.0)
  • Prior history of malignancy (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the patient has been free of disease for ≥5years
  • Patient received any chemotherapy, corticosteroids (> 10 mg/day prednisone or equivalent as a continuous dose) within 4 weeks before randomization
  • Previously treated with thalidomide or thalidomide derivatives
  • Patients refractory to high-dose dexamethasone (defined as experiencing less than a PR to dexamethasone, or PD within 6months after discontinuing dexamethasone, or discontinued dexamethasone because of ≥Grade 3 dexamethasone-related toxicity. Previous high-dose dexamethasone therapy is defined as >500mg dexamethasone or equivalent over a 10week period, whether administered alone or as part of the VAD regimen)
  • Contraindications for high-dose dexamethasone
  • Active or chronic gastrointestinal ulcers, active viral infections (herpes, varicella, HIV, hepatitis B, hepatitis C), glaucoma, uncontrolled hypertension, or diabetes mellitus, unless well controlled \& under strict supervision during dexamethasone treatment
  • Patient enrolled in another clinical trial or who have participated in another trial with the last 4weeks before randomization

Trial locations and contacts

86 sites in 15 countries.

86 sites in 15 countries

Germany15 sites

  • Charite, Universitatsmedizin Berlin, Campus Robert-Rossle Klinik

    Berlin, 13125

  • Med. Klinik I/University Bonn

    Bonn, 53105

  • Universitaetsklinik - Klinik fur innere Medizin

    Cologne, 50924

  • Medizinische Klinik und Poliklinik I/Carl-Gustav-Carus University

    Dresden, 01307

  • Hematology, Oncology & Clinical Immunology/Heinrich-Heine-University

    Düsseldorf, 40225

  • Abt. Haematologie - Onkologie/ Allg. Krankenhaus

    Hamburg, 22763

  • Allgemeinse Krankenhaus St. Georg Hamatologische Abteilung

    Hamburg, D-20099

  • Medizinische Klinik Abteilung Innere V/Universitatsklinikum

    Heidelberg, 69120

  • Universitat Schleswig Holstein II Med. Klinik

    Kiel, 24116

  • Medizinische Klinik und Poliklinik III/Klinikum der Universitaet Muenchen

    München, D-81377

  • Innere Medizin University Hospital

    Münster, 48149

  • Abteilung Haematologie - Univeresitaetsklinikum

    Saale, D-06120

  • Robert-Bosch-Krankenhaus GmbH, Stuttgart

    Stuttgart, 70376

  • Universitaetsklinik - Abteilung Innere Medizin III

    Ulm, 89081

  • Med. Klinik II/Klinikum of the Julius-Maximilians-University

    Würzburg, 97070

Other trials in Germany

Poland10 sites

  • SPSK, Klinika Hematologii Akademii Medycznej

    Bialystok, 15-276

  • Klinika Hematologii Akademii Medycznej w Gdanskuul

    Gdansk, 80-952

  • Katedra i Klinika Hematologii i Transplantacji Szpiku - Slaska Akademia Medyczna

    Katowice, 40-027

  • Swietokrzyskie Centrum Onkologii SPZOZ Poradnia Hematologii

    Kielce, 25-734

  • Klinika Hematologii Uniwersytetu Medycznego

    Lodz, 93-510

  • Klinika Chorob Wewnetrznych i Hemagologii

    Warsaw, 00-909

  • Katedra i Klinika Hematologii, Onkologii I Chorob Wewnetrznych

    Warsaw, 02-097

  • Instytut Hematologii i Transfuzjologii - Klinika Hematologiczna

    Warsaw, 02-776

  • Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie

    Warsaw, 02-781

  • Klinika Hematologii Nowotworow Krwi i Transplantacji - Szpiku Akademii Medycznej

    Wroclaw, 50-367

Other trials in Poland

India9 sites

  • Nizam's Institute of Medical Sciences, Department of Medical Oncology

    Hyderabaad, 500082

  • Department of Medical Oncology, Amrita Institute of Medical Sciences

    Kerala, 682 026

  • Orchid Nursing Home

    Kolkata, 700054

  • Department of Medical Oncology, Dayanand Medical College DMCH

    Ludhiana, 141 001

  • Department of Medical Oncology/Tata Memorial Hospital

    Mumbai, 400012

  • Department of Medical Oncology, S.L. Raheja Hospital

    Mumbai, 400016

  • Department of Medical Oncology, Jaslok Hospital and Research Centre

    Mumbai, 400026

  • Department of Medical Oncology, Deenanath Mangeshkar Hospital

    Pune, 411004

  • Department of Medical Oncology/Regional Cancer Centre

    Trivandrum, 695 011

Other trials in India

Bulgaria6 sites

  • Clinic of Haematology, University Multiprofiled Hospital for Active Treatment "G. Stranski"

    Pleven, 5800

  • Clinic of Haematology, University Multiprofiled Hospital for Active Treatment

    Plovdiv, 4002

  • University of Multiprofiled Hospital for Active Treatment "Alexandrovska" - Sofia

    Sofia, 1431

  • Military Medical Academy/Dept Haematology and Oncology

    Sofia, 1606

  • National Center of Haematology & Transfusiology

    Sofia, 1756

  • Clinic of Haematology, Multiprofiled Hospital for Active Treatment "Sveta Marina"

    Varna, 9010

Other trials in Bulgaria

Croatia6 sites

  • Klinicki Bolnicki Centar Rijeka Interna Klinika

    Rijeka, 51000

  • Klinika Bolnica SPLIT - Klinika za Unutarnje Bolesti

    Split, 21000

  • KBC Zagreb - Klinika za Unutarnje Bolesti

    Zagreb, 10000

  • Klinicka Bolnica "Dubrava" Klinika za Unutarnje Bolesti

    Zagreb, 10000

  • Klinicka Bolnica "Sestre milosrdnice" Klinika za Unutarnje Bolesti

    Zagreb, 10000

  • Klinicka Bolnica MERKUR - Klinika za Unutarnje Bolesti

    Zagreb, 10000

Other trials in Croatia

Czechia6 sites

  • Interni Hemato-Onkologicka Klinika

    Brno, 20 625 00

  • Hematologicka Klinika, Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 48 500 05

  • Onkologicke Centrum J.G. Mendela

    Novi Jicin, 73601

  • Interni Klinika, Oddeleni Hematoonkologie

    Olomouc, 6 775 20

  • Interni Klinika, Oddeleni Hematoonkologie

    Prague, 2128 08

  • Hematologicka Klinika, Fakultni Nemocnice Kralovske Vinohrady Srobarova

    Prague, 50 100 34

Other trials in Czechia

Philippines6 sites

  • Department of Internal Medicine - Baguio General Hospital & Medical Center

    Baguio City, 2600

  • Chong Hua Hospital

    Cebu City, 6000

  • Doctors Clinic Makati Medical Center

    Makati City, 1200

  • University of Sto Tomas Hospital

    Manila, 1108

  • Doctors Clinic - National Kidney & Transplant Institute

    Quezon City, 1100

  • St. Luke's Medical Center

    Quezon City, 1102

Other trials in Philippines

South Africa6 sites

  • University of Free State, Faculty of Health Science, Dept of Hematology & Cell Biology

    Bloemfontein, 9301

  • Tygerberg Hospital, University of Stellenbosch, Department of Haematology

    Cape Town, 7505

  • Department of Haematology, UCT Medical School

    Cape Town

  • Chris Hani Baragwanath Hospital, Clinical Haematology Unit

    Johannesburg, 2013

  • Medical Oncology Centre of Rosebank

    Johannesburg, 2196

  • Johannesburg Hospital, Department of Medical Oncology

    Parktown, 2193

Other trials in South Africa

Hungary4 sites

  • National Medical Centre Dpt Haematology

    Budapest, 351135

  • Petz Aladar Megyei Oktato Korhaz, II. Belgyogyaszat

    Győr, H-9024

  • Pandy Kalman Megyei Korhaz, Megyei Onkologiai Centrum

    Gyula, 5700

  • Szent-Gyorgyi Albert University II Clinic of Internal Medicine

    Szeged, 6720

Other trials in Hungary

United Kingdom4 sites

  • Oncology Research Unit Heartlands Hospital

    Birmingham, B95 SS

  • Clinical Haematology, Guy's Hospital

    London, SE1 9RT

  • Haematology Department - King's College Hospital

    London, SE5 9RS

  • Department of Haematology-Oncology, The Royal Marsden NHS Foundation Trust

    Surrey, SM2 5PT

Other trials in United Kingdom

France3 sites

  • CHRU de Lille - Hopital Claude Huriez

    Lille, 59037

  • CHU de Nancy - Hopital Brabois

    Nancy, 54511

  • Hematologie - CHU Purpan Place du Dr. Baylac

    Toulouse, 31059

Other trials in France

Portugal3 sites

  • Hospital da Universidade de Coimbra - Servico de Hematologia Clinica

    Coimbra, 3000-075

  • Instituto Portugues de Oncologia

    Lisbon, 1099-023

  • Hospital Geral de Santo Antonio - Servico de Hematologia Clinica

    Porto, 4099-001

Other trials in Portugal

Serbia3 sites

  • Institute of Hematology, Clinical Centre of Serbia

    Belgrade, 11000

  • Clinic for Hematology, Clinical Centre Nis

    Niš, 18000

  • Clinic for Hematology, Clinical Centre Novi Sad

    Novisad, 21000

Other trials in Serbia

Slovakia3 sites

  • Department of Internal Medicine, National Cancer Institute

    Bratilslava, 83310

  • Hematology Department University Hospital

    Bratilslava, 85107

  • Hematology Department, University Hospital PJS

    Košice, 04066

Other trials in Slovakia

Italy2 sites

  • Instituto di Ematologia e Oncologia Medica

    Bologna, 40138

  • Dipartimento Medicina ed Oncologia Sperimentale - Divisione Universitaria di Ematologia Azienda Ospedaliera S. Giovanni Battista

    Torino, 310126

Other trials in Italy

About this study

Official title: Randomised, Controlled, Open-labelled, Multi-centre Comparison of Thalidomide Versus High-dose Dexamethasone for the Treatment of Relapsed Refractory Multiple Myeloma

The primary objective is to compare the time to progression (TTP) of three daily doses of thalidomide (100, 200 and 400 mg) with high-dose dexamethasone in relapsed refractory multiple myeloma (MM) patients and to subsequently select the optimum thalidomide dose in terms of median TPP and toxicity.

Keywords
Relapsed Refractory 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.

  • ThalidomideDrug

    Oral thalidomide (100mg or 200mg or 400 mg/day) administered to the patient once daily until progression of the disease and for a maximum of 336 + 36 days (12 cycles of 28 +/- 3 days).

  • DexamethasoneDrug

    High dose oral dexamethasone will be administered at a dose of 40mg/day on days 1-4, 9-12 and 17-20 of each 28-day cycle for cycles 1-4. Beginning with cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg/day on days 1-4 of each 28-day cycle. Dexamethasone will be administered until progression of the disease and for a maximum of 336 +/- 36 days (12 cycles of 28 +/- 3 days).

Study groups in NCT00452569
Study groupRoleWhat they receive
AExperimentalOral thalidomide (100mg/day) administered to the patient once daily until progression of the disease and for a maximum of 336 +/- 36 days (12 cycles of 28 +/- 3 days).
Receives: Drug: Thalidomide
BExperimentalOral thalidomide (200mg/day) administered to the patient once daily until progression of the disease and for a maximum of 336 +/- 36 days (12 cycles of 28 +/- 3 days).
Receives: Drug: Thalidomide
CExperimentalOral thalidomide (400mg/day) administered to the patient once daily until progression of the disease and for a maximum of 336 +/- 36 days (12 cycles of 28 +/- 3 days).
Receives: Drug: Thalidomide
DActive comparatorHigh dose oral dexamethasone will be administered at a dose of 40mg/day on days 1-4, 9-12 and 17-20 of each 28-day cycle for cycles 1-4. Beginning with cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg/day on days 1-4 of each 28-day cycle. Dexamethasone will be administered until progression of the disease and for a maximum of 336 +/- 36 days (12 cycles of 28 +/- 3 days).
Receives: Drug: Dexamethasone

What is being measured

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

  1. The evaluation of Independent Review Committee-documented time to progression (TTP).

    Measured: >160 "IRC confirmed" disease progression in the Dexamethasone or Thalidomide 400 mg/day arms

Secondary outcomes (11)

  1. Response rate (CR + PR), according to the EBMT criteria

    Measured: Every 4 weeks

  2. Response duration

    Measured: Every 4 weeks

  3. Clinical benefit as measured by ECOG performance status, transfusion requirement and Grade ≥3 infections (assessed by the National Cancer Institute Common Toxicity Criteria)

    Measured: Every 4 weeks

  4. Progression-free survival (PFS)

    Measured: Disease progression evaluated every 4 weeks

  5. Overall survival (OS)

    Measured: Evaluated after 150 deaths occurring in Dexamethasone and Thalidomide 400 mg arms

  6. Composite of disease progression and death (recurrent time(s) from randomisation to disease progression and/or death)

    Measured: Evaluated after 160 "IRC confirmed" disease progression in the Dexamethasone or Thalidomide 400 mg/day arms

  7. Quality of life as determined by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)

    Measured: Baseline/Week 8/ Week 16/Week 24/Week 32/Week 40/Week 48

  8. Adverse events (AEs)

    Measured: Every 4 weeks

  9. Assessment of peripheral neuropathy

    Measured: Screening, Week 24, Week 48

  10. Vital signs and physical examination

    Measured: Every 4 weeks

  11. Clinical laboratory tests

    Measured: Every 4 weeks

Timeline

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

  1. First posted27 Mar 2007 (estimated)
  2. Study start1 Feb 2006
  3. Primary completion1 Dec 2008
  4. Study completion1 Jan 2009

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
None (open label)
Enrolment
499 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00452569
Sponsor's protocol ID
THA PH INT 2005 CL001
Acronym
OPTIMUM
Status last verified
Nov 2019
First submitted
23 Mar 2007
Last updated
18 Nov 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Kropff M, Baylon HG, Hillengass J, Robak T, Hajek R, Liebisch P, Goranov S, Hulin C, Blade J, Caravita T, Avet-Loiseau H, Moehler TM, Pattou C, Lucy L, Kueenburg E, Glasmacher A, Zerbib R, Facon T. Thalidomide versus dexamethasone for the treatment of relapsed and/or refractory multiple myeloma: results from OPTIMUM, a randomized trial. Haematologica. 2012 May;97(5):784-91. doi: 10.3324/haematol.2011.044271. Epub 2011 Dec 1.

    PubMed 22133776

  • Kropff M, et al. OPTIMUM Dose of Thalidomide for Relapsed Multiple Myeloma. Presented at American Society of Hematology 2009, New Orleans, LA. Abstract No. 959

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Thalidomide and Dexamethasone in people with Multiple Myeloma, run by Celgene at 86 sites in 15 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 9 inclusion and 15 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 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in Germany, Poland, India, Bulgaria, Croatia and 10 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. 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?

The evaluation of Independent Review Committee-documented time to progression (TTP). (time frame: >160 "IRC confirmed" disease progression in the Dexamethasone or Thalidomide 400 mg/day arms). 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 NCT00452569, which also lists 2 linked publications.

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 18 Nov 2019.

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