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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Thalidomide
Dexamethasone
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Relapsed Refractory Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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)
  • 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

Sites / Locations

  • Clinic of Haematology, University Multiprofiled Hospital for Active Treatment "G. Stranski"
  • Clinic of Haematology, University Multiprofiled Hospital for Active Treatment
  • University of Multiprofiled Hospital for Active Treatment "Alexandrovska" - Sofia
  • Military Medical Academy/Dept Haematology and Oncology
  • National Center of Haematology & Transfusiology
  • Clinic of Haematology, Multiprofiled Hospital for Active Treatment "Sveta Marina"
  • Klinicki Bolnicki Centar Rijeka Interna Klinika
  • Klinika Bolnica SPLIT - Klinika za Unutarnje Bolesti
  • KBC Zagreb - Klinika za Unutarnje Bolesti
  • Klinicka Bolnica "Dubrava" Klinika za Unutarnje Bolesti
  • Klinicka Bolnica "Sestre milosrdnice" Klinika za Unutarnje Bolesti
  • Klinicka Bolnica MERKUR - Klinika za Unutarnje Bolesti
  • Interni Hemato-Onkologicka Klinika
  • Hematologicka Klinika, Fakultni Nemocnice Hradec Kralove
  • Onkologicke Centrum J.G. Mendela
  • Interni Klinika, Oddeleni Hematoonkologie
  • Hematologicka Klinika, Fakultni Nemocnice Kralovske Vinohrady Srobarova
  • Interni Klinika, Oddeleni Hematoonkologie
  • CHRU de Lille - Hopital Claude Huriez
  • CHU de Nancy - Hopital Brabois
  • Hematologie - CHU Purpan Place du Dr. Baylac
  • Charite, Universitatsmedizin Berlin, Campus Robert-Rossle Klinik
  • Med. Klinik I/University Bonn
  • Medizinische Klinik und Poliklinik I/Carl-Gustav-Carus University
  • Hematology, Oncology & Clinical Immunology/Heinrich-Heine-University
  • Abt. Haematologie - Onkologie/ Allg. Krankenhaus
  • Allgemeinse Krankenhaus St. Georg Hamatologische Abteilung
  • Medizinische Klinik Abteilung Innere V/Universitatsklinikum
  • Universitat Schleswig Holstein II Med. Klinik
  • Universitaetsklinik - Klinik fur innere Medizin
  • Medizinische Klinik und Poliklinik III/Klinikum der Universitaet Muenchen
  • Innere Medizin University Hospital
  • Abteilung Haematologie - Univeresitaetsklinikum
  • Robert-Bosch-Krankenhaus GmbH, Stuttgart
  • Universitaetsklinik - Abteilung Innere Medizin III
  • Med. Klinik II/Klinikum of the Julius-Maximilians-University
  • National Medical Centre Dpt Haematology
  • Petz Aladar Megyei Oktato Korhaz, II. Belgyogyaszat
  • Pandy Kalman Megyei Korhaz, Megyei Onkologiai Centrum
  • Szent-Gyorgyi Albert University II Clinic of Internal Medicine
  • Nizam's Institute of Medical Sciences, Department of Medical Oncology
  • Department of Medical Oncology, Amrita Institute of Medical Sciences
  • Orchid Nursing Home
  • Department of Medical Oncology, Dayanand Medical College DMCH
  • Department of Medical Oncology/Tata Memorial Hospital
  • Department of Medical Oncology, S.L. Raheja Hospital
  • Department of Medical Oncology, Jaslok Hospital and Research Centre
  • Department of Medical Oncology, Deenanath Mangeshkar Hospital
  • Department of Medical Oncology/Regional Cancer Centre
  • Instituto di Ematologia e Oncologia Medica
  • Dipartimento Medicina ed Oncologia Sperimentale - Divisione Universitaria di Ematologia Azienda Ospedaliera S. Giovanni Battista
  • Department of Internal Medicine - Baguio General Hospital & Medical Center
  • Chong Hua Hospital
  • Doctors Clinic Makati Medical Center
  • University of Sto Tomas Hospital
  • Doctors Clinic - National Kidney & Transplant Institute
  • St. Luke's Medical Center
  • SPSK, Klinika Hematologii Akademii Medycznej
  • Klinika Hematologii Akademii Medycznej w Gdanskuul
  • Katedra i Klinika Hematologii i Transplantacji Szpiku - Slaska Akademia Medyczna
  • Swietokrzyskie Centrum Onkologii SPZOZ Poradnia Hematologii
  • Klinika Hematologii Uniwersytetu Medycznego
  • Klinika Chorob Wewnetrznych i Hemagologii
  • Katedra i Klinika Hematologii, Onkologii I Chorob Wewnetrznych
  • Instytut Hematologii i Transfuzjologii - Klinika Hematologiczna
  • Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
  • Klinika Hematologii Nowotworow Krwi i Transplantacji - Szpiku Akademii Medycznej
  • Hospital da Universidade de Coimbra - Servico de Hematologia Clinica
  • Instituto Portugues de Oncologia
  • Hospital Geral de Santo Antonio - Servico de Hematologia Clinica
  • Institute of Hematology, Clinical Centre of Serbia
  • Clinic for Hematology, Clinical Centre Nis
  • Clinic for Hematology, Clinical Centre Novi Sad
  • Department of Internal Medicine, National Cancer Institute
  • Hematology Department University Hospital
  • Hematology Department, University Hospital PJS
  • University of Free State, Faculty of Health Science, Dept of Hematology & Cell Biology
  • Tygerberg Hospital, University of Stellenbosch, Department of Haematology
  • Department of Haematology, UCT Medical School
  • Chris Hani Baragwanath Hospital, Clinical Haematology Unit
  • Medical Oncology Centre of Rosebank
  • Johannesburg Hospital, Department of Medical Oncology
  • Oncology Research Unit Heartlands Hospital
  • Clinical Haematology, Guy's Hospital
  • Haematology Department - King's College Hospital
  • Department of Haematology-Oncology, The Royal Marsden NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

A

B

C

D

Arm Description

Oral 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).

Oral 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).

Oral 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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Response rate (CR + PR), according to the EBMT criteria
Response duration
Clinical benefit as measured by ECOG performance status, transfusion requirement and Grade ≥3 infections (assessed by the National Cancer Institute Common Toxicity Criteria)
Progression-free survival (PFS)
Overall survival (OS)
Composite of disease progression and death (recurrent time(s) from randomisation to disease progression and/or death)
Quality of life as determined by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)
Adverse events (AEs)
Assessment of peripheral neuropathy
Vital signs and physical examination
Clinical laboratory tests

Full Information

First Posted
March 23, 2007
Last Updated
November 14, 2019
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT00452569
Brief Title
Efficacy and Safety Study of 3 Thalidomide Doses for the Treatment of Relapsed Refractory Multiple Myeloma
Acronym
OPTIMUM
Official Title
Randomised, Controlled, Open-labelled, Multi-centre Comparison of Thalidomide Versus High-dose Dexamethasone for the Treatment of Relapsed Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2006 (Actual)
Primary Completion Date
December 1, 2008 (Actual)
Study Completion Date
January 1, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Relapsed Refractory Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
499 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Oral 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).
Arm Title
B
Arm Type
Experimental
Arm Description
Oral 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).
Arm Title
C
Arm Type
Experimental
Arm Description
Oral 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).
Arm Title
D
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
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).
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Response rate (CR + PR), according to the EBMT criteria
Time Frame
Every 4 weeks
Title
Response duration
Time Frame
Every 4 weeks
Title
Clinical benefit as measured by ECOG performance status, transfusion requirement and Grade ≥3 infections (assessed by the National Cancer Institute Common Toxicity Criteria)
Time Frame
Every 4 weeks
Title
Progression-free survival (PFS)
Time Frame
Disease progression evaluated every 4 weeks
Title
Overall survival (OS)
Time Frame
Evaluated after 150 deaths occurring in Dexamethasone and Thalidomide 400 mg arms
Title
Composite of disease progression and death (recurrent time(s) from randomisation to disease progression and/or death)
Time Frame
Evaluated after 160 "IRC confirmed" disease progression in the Dexamethasone or Thalidomide 400 mg/day arms
Title
Quality of life as determined by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)
Time Frame
Baseline/Week 8/ Week 16/Week 24/Week 32/Week 40/Week 48
Title
Adverse events (AEs)
Time Frame
Every 4 weeks
Title
Assessment of peripheral neuropathy
Time Frame
Screening, Week 24, Week 48
Title
Vital signs and physical examination
Time Frame
Every 4 weeks
Title
Clinical laboratory tests
Time Frame
Every 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Kropff, MD
Organizational Affiliation
Universitatsklinikum Munster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic of Haematology, University Multiprofiled Hospital for Active Treatment "G. Stranski"
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Clinic of Haematology, University Multiprofiled Hospital for Active Treatment
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
University of Multiprofiled Hospital for Active Treatment "Alexandrovska" - Sofia
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Military Medical Academy/Dept Haematology and Oncology
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
National Center of Haematology & Transfusiology
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Clinic of Haematology, Multiprofiled Hospital for Active Treatment "Sveta Marina"
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Klinicki Bolnicki Centar Rijeka Interna Klinika
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Klinika Bolnica SPLIT - Klinika za Unutarnje Bolesti
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
KBC Zagreb - Klinika za Unutarnje Bolesti
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicka Bolnica "Dubrava" Klinika za Unutarnje Bolesti
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicka Bolnica "Sestre milosrdnice" Klinika za Unutarnje Bolesti
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicka Bolnica MERKUR - Klinika za Unutarnje Bolesti
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Interni Hemato-Onkologicka Klinika
City
Brno
ZIP/Postal Code
20 625 00
Country
Czechia
Facility Name
Hematologicka Klinika, Fakultni Nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
48 500 05
Country
Czechia
Facility Name
Onkologicke Centrum J.G. Mendela
City
Novi Jicin
ZIP/Postal Code
73601
Country
Czechia
Facility Name
Interni Klinika, Oddeleni Hematoonkologie
City
Olomouc
ZIP/Postal Code
6 775 20
Country
Czechia
Facility Name
Hematologicka Klinika, Fakultni Nemocnice Kralovske Vinohrady Srobarova
City
Prague 10
ZIP/Postal Code
50 100 34
Country
Czechia
Facility Name
Interni Klinika, Oddeleni Hematoonkologie
City
Prague 2
ZIP/Postal Code
2128 08
Country
Czechia
Facility Name
CHRU de Lille - Hopital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de Nancy - Hopital Brabois
City
Nancy Cedex
ZIP/Postal Code
54511
Country
France
Facility Name
Hematologie - CHU Purpan Place du Dr. Baylac
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Charite, Universitatsmedizin Berlin, Campus Robert-Rossle Klinik
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Med. Klinik I/University Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Medizinische Klinik und Poliklinik I/Carl-Gustav-Carus University
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Hematology, Oncology & Clinical Immunology/Heinrich-Heine-University
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Abt. Haematologie - Onkologie/ Allg. Krankenhaus
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Allgemeinse Krankenhaus St. Georg Hamatologische Abteilung
City
Hamburg
ZIP/Postal Code
D-20099
Country
Germany
Facility Name
Medizinische Klinik Abteilung Innere V/Universitatsklinikum
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitat Schleswig Holstein II Med. Klinik
City
Kiel
ZIP/Postal Code
24116
Country
Germany
Facility Name
Universitaetsklinik - Klinik fur innere Medizin
City
Koeln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Medizinische Klinik und Poliklinik III/Klinikum der Universitaet Muenchen
City
Muenchen
ZIP/Postal Code
D-81377
Country
Germany
Facility Name
Innere Medizin University Hospital
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Abteilung Haematologie - Univeresitaetsklinikum
City
Saale
ZIP/Postal Code
D-06120
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus GmbH, Stuttgart
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Universitaetsklinik - Abteilung Innere Medizin III
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Med. Klinik II/Klinikum of the Julius-Maximilians-University
City
Wuerzburg
ZIP/Postal Code
97070
Country
Germany
Facility Name
National Medical Centre Dpt Haematology
City
Budapest
ZIP/Postal Code
351135
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz, II. Belgyogyaszat
City
Gyor
ZIP/Postal Code
H-9024
Country
Hungary
Facility Name
Pandy Kalman Megyei Korhaz, Megyei Onkologiai Centrum
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Szent-Gyorgyi Albert University II Clinic of Internal Medicine
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Nizam's Institute of Medical Sciences, Department of Medical Oncology
City
Hyderabaad
ZIP/Postal Code
500082
Country
India
Facility Name
Department of Medical Oncology, Amrita Institute of Medical Sciences
City
Kerala
ZIP/Postal Code
682 026
Country
India
Facility Name
Orchid Nursing Home
City
Kolkata
ZIP/Postal Code
700054
Country
India
Facility Name
Department of Medical Oncology, Dayanand Medical College DMCH
City
Ludhiana
ZIP/Postal Code
141 001
Country
India
Facility Name
Department of Medical Oncology/Tata Memorial Hospital
City
Mumbai
ZIP/Postal Code
400012
Country
India
Facility Name
Department of Medical Oncology, S.L. Raheja Hospital
City
Mumbai
ZIP/Postal Code
400016
Country
India
Facility Name
Department of Medical Oncology, Jaslok Hospital and Research Centre
City
Mumbai
ZIP/Postal Code
400026
Country
India
Facility Name
Department of Medical Oncology, Deenanath Mangeshkar Hospital
City
Pune
ZIP/Postal Code
411004
Country
India
Facility Name
Department of Medical Oncology/Regional Cancer Centre
City
Trivandrum
ZIP/Postal Code
695 011
Country
India
Facility Name
Instituto di Ematologia e Oncologia Medica
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Dipartimento Medicina ed Oncologia Sperimentale - Divisione Universitaria di Ematologia Azienda Ospedaliera S. Giovanni Battista
City
Torino
ZIP/Postal Code
310126
Country
Italy
Facility Name
Department of Internal Medicine - Baguio General Hospital & Medical Center
City
Baguio City
ZIP/Postal Code
2600
Country
Philippines
Facility Name
Chong Hua Hospital
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Doctors Clinic Makati Medical Center
City
Makati City
ZIP/Postal Code
1200
Country
Philippines
Facility Name
University of Sto Tomas Hospital
City
Manila City
ZIP/Postal Code
1108
Country
Philippines
Facility Name
Doctors Clinic - National Kidney & Transplant Institute
City
Quezon City
ZIP/Postal Code
1100
Country
Philippines
Facility Name
St. Luke's Medical Center
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Facility Name
SPSK, Klinika Hematologii Akademii Medycznej
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Klinika Hematologii Akademii Medycznej w Gdanskuul
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Katedra i Klinika Hematologii i Transplantacji Szpiku - Slaska Akademia Medyczna
City
Katowice
ZIP/Postal Code
40-027
Country
Poland
Facility Name
Swietokrzyskie Centrum Onkologii SPZOZ Poradnia Hematologii
City
Kielce
ZIP/Postal Code
25-734
Country
Poland
Facility Name
Klinika Hematologii Uniwersytetu Medycznego
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Klinika Chorob Wewnetrznych i Hemagologii
City
Warszawa
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Katedra i Klinika Hematologii, Onkologii I Chorob Wewnetrznych
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Instytut Hematologii i Transfuzjologii - Klinika Hematologiczna
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Klinika Hematologii Nowotworow Krwi i Transplantacji - Szpiku Akademii Medycznej
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Hospital da Universidade de Coimbra - Servico de Hematologia Clinica
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Instituto Portugues de Oncologia
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Hospital Geral de Santo Antonio - Servico de Hematologia Clinica
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Institute of Hematology, Clinical Centre of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinic for Hematology, Clinical Centre Nis
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Clinic for Hematology, Clinical Centre Novi Sad
City
Novisad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Department of Internal Medicine, National Cancer Institute
City
Bratilslava
ZIP/Postal Code
83310
Country
Slovakia
Facility Name
Hematology Department University Hospital
City
Bratilslava
ZIP/Postal Code
85107
Country
Slovakia
Facility Name
Hematology Department, University Hospital PJS
City
Kosice
ZIP/Postal Code
04066
Country
Slovakia
Facility Name
University of Free State, Faculty of Health Science, Dept of Hematology & Cell Biology
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Tygerberg Hospital, University of Stellenbosch, Department of Haematology
City
Cape Town
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Department of Haematology, UCT Medical School
City
Cape Town
Country
South Africa
Facility Name
Chris Hani Baragwanath Hospital, Clinical Haematology Unit
City
Johannesburg
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Medical Oncology Centre of Rosebank
City
Johannesburg
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Johannesburg Hospital, Department of Medical Oncology
City
Parktown
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Oncology Research Unit Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B95 SS
Country
United Kingdom
Facility Name
Clinical Haematology, Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Haematology Department - King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Department of Haematology-Oncology, The Royal Marsden NHS Foundation Trust
City
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22133776
Citation
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.
Results Reference
background
Citation
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
Results Reference
background

Learn more about this trial

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

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