A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

September 18, 2017 updated by: Celgene

The Official Title is A Multi-center, Randomized, Parallel-group, Double-blind, Placebo Controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma.

To compare the efficacy of oral CC-5013 in combination with oral pulse high-dose dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for subjects with relapsed or refractory multiple myeloma."

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

351

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Box Hill, Australia, VIC 3128
        • Box Hill Hospital
      • Frankston, Australia, VIC 3199
        • Frankston Hospital Oncology Research
      • Herston, Australia, QLD4029
        • Royal Brisbane Hospital
      • Parkville, Australia, 3050
        • The Royal Melbourne Hospital
      • South Brisbane, Australia, QLD 4101
        • Mater Public Hospital
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
    • Victoria
      • East Melbourne, Victoria, Australia, 3006
        • Peter MacCallum Cancer Centre Divsion of Haematology/Medical Oncology
      • Prahran, Victoria, Australia, 3121
        • The Alfred Hospital
      • Wodonga, Victoria, Australia, 3690
        • Border Medical Oncology
  • Austria
      • Salzburg, Austria, A -5020
        • University Hospital of Salzburg St Johanns Spital
      • Vienna, Austria, 1160
        • Wilhelminenspital
  • Belgium
      • Brussel, Belgium, 1200
        • CHU Saint-Luc
      • Leuven, Belgium, 3000
        • UZ Gasthuisberg
  • France
      • Chemin Grand Revoyet, France, 69495 Pierre Benite cedex
        • Centre Hospitalier Lyon Sud
      • Lille, France, 59037
        • Hôpital Claude Huriez
      • Nantes, France
        • Centre Hospitalier Hotel-Dieu
      • Paris, France, 75010
        • Hopital Saint-Loius
      • Pessac, France, 33640
        • Chu de Bordeaux Groupe Hospitalier Sud
      • Toulouse cedex 9, France, TSA 40031-31059
        • CHU Purpan
      • Vandoeuvre, France, 54511
        • CHU Nancy - Hôpital Brabois
  • Germany
      • Berlin, Germany, 13125
        • Universitaetsklinikum Charite
      • Berlin, Germany, 13353
        • Universitatsklinik ChariteMedizinische Fakultaet der HumboldtUniversitaet zu Berlin
      • Dusseldorf, Germany, 40225
        • Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
      • Erlangen, Germany, 91054
        • Universitaetsklinkum Erlangen
      • Frankfurt am Main, Germany, 60590
        • Klininkum der Johann-Wolfgang-Goethe-Universtat
      • Heidelberg, Germany, 69120
        • Universitaetsklinikum Heidelberg Medizinische Klinik und Poliklinik V
      • Muenster, Germany, 48129
        • Universitatsklinik Muenster Medizinische Klinik A
      • Munchen, Germany, 80336
        • Klinikum der Univeristact Muenchen
      • Tubingen, Germany, 72076
        • Universitaetsklinikum Tuebingen
  • Greece
      • Athens, Greece, 11538
        • "Alexandras" General Hospital of Athens
  • Ireland
      • Belfast, Ireland, BT9 7AB
        • Belfast City HospitalHaematology Department
      • Dublin 8, Ireland
        • Hope Directorate Haematology Oncology Service St. James Hospital
      • Limerick, Ireland
        • Midwestern Regional Hospital
    • Co. Galway
      • Galway, Co. Galway, Ireland
        • University Hospital GalwayHaematology Department
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Jerusalem, Israel
        • Hadassah University Hospital
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center Department of Hematology
      • Tel Hashomer, Israel, 52621
        • The Chaim Sheba Medical Center
  • Italy
      • Bologna, Italy, 40138
        • Policlinico Sant'Orsola-Malpighi
      • Genova, Italy, 16132
        • Azienda Ospedaliera San Martino
      • Milano, Italy, 20162
        • Ospedale Niguarda Cà Granda
      • Pavia, Italy, 27100
        • Policlinico San Matteo
      • Roma, Italy, 00161
        • Univerita La Sapien
      • Torio, Italy, 10126
        • Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
      • Udine, Italy, 33100
        • Policlinico Universitario a Gesttione diretta di Udine
  • Poland
      • Gdansk, Poland, 80-211
        • Institute of Internal Diseases University of Medicine
      • Lublin, Poland, 20-290
        • University School of Medicine
      • Warsaw, Poland, 00-957
        • Institute of Haematology and Blood Transfusion
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic
      • Madrid, Spain, 28041
        • Hospital Doce de Octubre
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princessa
      • Pamplona, Spain, 31080
        • Clinica Universitaria de Navarra
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
      • Santander, Spain, 39008
        • Hospital Universtario Marques de Valdecilla
  • Sweden
      • Goteborg, Sweden, S-413 45
        • Sahlgrenska University Hospital Department of Hematology and Coagulation
  • Switzerland
      • Lausanne, Switzerland, 1011
        • Centre Hospitalier Universitaire Vaudois (CHUV)
      • St. Gallen, Switzerland
        • Kantonsspital St. Gallen
      • Zürich, Switzerland, 8091
        • Universitatsspital Zurich
  • Ukraine
      • Cherkassy, Ukraine, 18009
        • Cherkassy Regional Oncology Center
      • Dnepropetrovsk, Ukraine, 49044
        • Dnepropetrovsk City Clinical Hospital #4
      • Kiev, Ukraine, 04060
        • Institute of Hematology and Transfusiology of the UAMS Department of blood diseases
      • Kiev, Ukraine, 03115
        • Kiev Bone Marrow Transplantation Center Bone Marrow Department
      • Lviv, Ukraine, 79044
        • Institute of Blood Pathology and Transfusion Medicine of the UAMS
      • Lvov, Ukraine, 79044
        • Institute of Blood Pathology and Transfusion Medicine of the UAMS Hematology Department
      • Odessa, Ukraine, 65025
        • Odess Regional Clinical Hospital
      • Zhitomir, Ukraine, 10003
        • Zhitomir Regional Clinical Hospital
  • United Kingdom
      • Bristol, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • London, United Kingdom, SE1 9RT
        • Haematology Dept, 4th Floor Thomas Guy House
    • Bloomsbury
      • London, Bloomsbury, United Kingdom, WC1E 6AU
        • University College Hospital Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Prior or current diagnosis Durie-Salmon stage II or III multiple myeloma.
  • Measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample).
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0,1, or 2
  • Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug

Exclusion Criteria:

  • Prior development of disease progression during high-dose dexamethasone containing therapy
  • Pregnant or lactating females
  • The development of a desquamating rash while taking thalidomide
  • Use of any standard/experimental anti-myeloma therapy within 28 days of randomization or use of any experimental non-drug therapy within 56 days of initiation of drug treatment
  • Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm3
  • Laboratory abnormalities: Platelet count < 75,000/mm3
  • Laboratory abnormalities: Serum creatinine > 2.5 mg/dL
  • Laboratory abnormalities: Serum Serum glutamic oxaloacetic transaminase (SGOT)/Aspartate aminotransferase (AST) or Serum glutamic pyruvic transaminase (SGPT)/Alanine aminotransferase (ALT) > 3.0 x upper limit of normal
  • Laboratory abnormalities: Serum total bilirubin > 2.0 mg/dL
  • Prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for ≥ 3 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CC-5013 plus dexamethasone
Arm A: Oral CC-5013 is initiated on Day 1 of Cycle 1 at a dose of 25 mg daily for 21 days every 28 days. Therefore, the subject will take a placebo identical in appearance to the CC-5013 capsule for week 4 of every 28 days. Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral CC-5013 placebo capsules will be administered for 28 days of every cycle.
Drug: CC-5013 plus dexamethasone
25 mg daily for 21 days every 28 days.
Other Names:
  • Revlimid
  • lenalidomide
EXPERIMENTAL: Dexamethasone plus placebo
Arm B: Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral placebo capsules will be administered for 28 days of every cycle.
Drug: Dexamethasone plus Placebo
Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral placebo capsules will be administered for 28 days of every cycle.
Other Names:
  • Dexamethasone
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kaplan-Meier Estimate of Time to Tumor Progression (TTP)
Time Frame: From randomization up to cut-off date of 03 August 2005; up to 24 months
Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
From randomization up to cut-off date of 03 August 2005; up to 24 months
Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (Later Cut-off Date of 02 Mar 2008)
Time Frame: From randomization up to cut-off date of 02 March 2008; up to 51 months
Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
From randomization up to cut-off date of 02 March 2008; up to 51 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kaplan-Meier Estimate of Overall Survival (OS)
Time Frame: Randomization to data cut off of 03 August 2005; up to 24 months
OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
Randomization to data cut off of 03 August 2005; up to 24 months
Kaplan-Meier Estimate of Overall Survival (OS) (Later Cut-off Date of 02 March 2008)
Time Frame: Randomization to data cut off of 02 March 2008; up to 51 months
OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
Randomization to data cut off of 02 March 2008; up to 51 months
Summary of Myeloma Response Rates Based on Best Response Assessment
Time Frame: Randomization to 03 August 2005; up to 24 months
Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.
Randomization to 03 August 2005; up to 24 months
Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008)
Time Frame: Randomization to data cut-off of 02 Mar 2008; up to 51 months
Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.
Randomization to data cut-off of 02 Mar 2008; up to 51 months
Number of Participants With Adverse Events (AE)
Time Frame: From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 25 June 2013; up to 90 months

An AE is any sign, symptom, illness, or diagnosis that appears or worsens during the course of the study. Treatment-emergent AEs (TEAEs) are any AE occurring or worsening on or after the first treatment of the study drug and within 30 days after the last cycle end date of study drug. A serious AE = any AE which results in death; is life-threatening; requires or prolongs existing inpatient hospitalization; results in persistent or significant disability is a congenital anomaly/birth defect; constitutes an important medical event.

The severity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE, Version 2.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.
From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 25 June 2013; up to 90 months
Time to First Symptomatic Skeletal-related Event (SRE) (Clinical Need for Radiation or Surgery to Bone)
Time Frame: Up to unblinding data cut off of 03 August 2005; up to 24 months
Time from randomization to the date of the first occurrence of a symptomatic SRE (clinical need for radiotherapy or surgery to bone).
Up to unblinding data cut off of 03 August 2005; up to 24 months
Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Time Frame: Randomization to cut off date of 03 August 2005; up to 24 months
The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.
Randomization to cut off date of 03 August 2005; up to 24 months
Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Later Cut-off Date of 02 March 2008)
Time Frame: Randomization to cut off date of 02 March 2008; up to 51 months
The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.
Randomization to cut off date of 02 March 2008; up to 51 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2003

Primary Completion (ACTUAL)

November 1, 2005

Study Completion (ACTUAL)

November 12, 2013

Study Registration Dates

First Submitted

January 17, 2007

First Submitted That Met QC Criteria

January 17, 2007

First Posted (ESTIMATE)

January 18, 2007

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2017

Last Update Submitted That Met QC Criteria

September 18, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-5013-MM-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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