Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects 65 Years Old or Older.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00405756
First received: November 29, 2006
Last updated: May 11, 2016
Last verified: May 2016
Results First Received: April 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Newly Diagnosed Multiple Myeloma
Interventions: Drug: Lenalidomide: Double-blind Induction
Drug: Melphalan
Drug: Prednisone
Drug: Aspirin
Drug: Placebo
Drug: Lenalidomide: Double-blind Maintenance
Drug: Lenalidomide: Open-label

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Data represents a May 11, 2010 data cut-off. The study is ongoing.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 606 subjects screened for this study, 147 failed screening. Reasons for screen failures included: laboratory values not met (45 subjects); diagnostic criteria for measurable multiple myeloma not met (30 subjects); other inclusion/exclusion criteria not met (30 subjects); subject withdrawal of consent (14 subjects); and other (28 subjects).

Reporting Groups
  Description
MPR+R Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
MPR+p Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
MPp+p Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.

Participant Flow for 3 periods

Period 1:   Double-blind Treatment
    MPR+R   MPR+p   MPp+p
STARTED   152 [1]   153   154 
Safety Population   150 [2]   152   153 
COMPLETED   0 [3]   0   0 
NOT COMPLETED   152   153   154 
Ongoing in Double-blind Treatment                45                24                18 
Adverse Event                31                27                12 
Disease Progression                47                81                102 
Lack of Efficacy                1                4                2 
Withdrawal by Subject                15                9                10 
Lost to Follow-up                1                0                0 
Death                4                4                4 
Protocol Violation                1                0                2 
Not Specified                7                4                4 
[1] Intent to treat population of all randomized participants
[2] Participants who took at least one dose of study drug.
[3] Double-blind Treatment Period had no defined completion.

Period 2:   Open-label Extension
    MPR+R   MPR+p   MPp+p
STARTED   19   47   72 
COMPLETED   0 [1]   0   0 
NOT COMPLETED   19   47   72 
Ongoing in Open Label Period                7                15                25 
Adverse Event                1                3                7 
Disease Progression                8                23                26 
Withdrawal by Subject                2                3                3 
Death                1                2                4 
Unspecified                0                1                7 
[1] Participants continue until disease progression or other reason for discontinuing.

Period 3:   Follow-up
    MPR+R   MPR+p   MPp+p
STARTED   75 [1]   90 [2]   88 [3] 
COMPLETED   0   0   0 
NOT COMPLETED   75   90   88 
Ongoing in Follow-up Period                52                51                60 
Death                21                31                24 
Lost to Follow-up                2                8                4 
[1] 66 participants from Double-blind and 9 from the Open Label Extension
[2] 65 participants from the Double-blind and 25 from the Open Label Extension
[3] 52 participants from the Double-blind and 36 from the Open Label Extension



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
MPR+R Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
MPR+p Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
MPp+p Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
Total Total of all reporting groups

Baseline Measures
   MPR+R   MPR+p   MPp+p   Total 
Overall Participants Analyzed 
[Units: Participants]
 152   153   154   459 
Age 
[Units: Years]
Mean (Standard Deviation)
 72.0  (5.33)   72.1  (5.20)   72.0  (5.26)   72.0  (5.25) 
Age, Customized 
[Units: Participants]
       
<=75 years   116   116   116   348 
>75 years   36   37   38   111 
Gender 
[Units: Participants]
       
Female   81   71   79   231 
Male   71   82   75   228 
Race/Ethnicity, Customized 
[Units: Participants]
       
White   151   151   151   453 
Black   1   0   0   1 
Hispanic   0   0   1   1 
Asian / Pacific Islander   0   0   0   0 
American Indian or Alaska Native   0   0   0   0 
Other   0   2   2   4 
Weight 
[Units: Kilograms]
Mean (Standard Deviation)
 73.5  (14.77)   72.0  (12.79)   72.1  (15.20)   72.5  (14.28) 
Height 
[Units: Centimeter]
Mean (Standard Deviation)
 164.8  (9.81)   165.3  (9.33)   165.7  (9.79)   165.3  (9.63) 
Systolic Blood Pressure 
[Units: mmHg]
Mean (Standard Deviation)
 133.9  (17.71)   135.5  (18.60)   136.4  (20.13)   135.3  (18.83) 
Diastolic Blood Pressure 
[Units: mmHg]
Mean (Standard Deviation)
 78.5  (9.53)   77.4  (9.99)   78.8  (10.40)   78.2  (9.98) 
Temperature 
[Units: Degrees centigrade]
Mean (Standard Deviation)
 36.5  (0.41)   36.5  (0.38)   36.5  (0.40)   36.5  (0.40) 
Pulse 
[Units: Beats per minute]
Mean (Standard Deviation)
 76.0  (9.77)   77.3  (10.50)   76.3  (10.80)   76.5  (10.36) 
Karnofsky Performance Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 81.1  (11.95)   82.2  (11.71)   84.0  (11.46)   82.4  (11.74) 
[1] Karnofsky Performance Scale classifies patients according to their functional impairment. Scores range from 0-100, the lower the score, the greater the impairment and worse prospect of survival for most serious illnesses.
International Staging System (ISS) [1] 
[Units: Participants]
       
Stage I   28   32   28   88 
Stage II   50   47   48   145 
Stage III   74   74   78   226 
[1] ISS form multiple myeloma divides myeloma into 3 stages based only on the serum beta-2 microglobulin and serum albumin levels. Higher stages represent more advanced disease.
Creatinine clearance 
[Units: Participants]
       
>=60 ml/min   72   83   77   232 
<60 ml/min   78   69   76   223 
Missing   2   1   1   4 
Beta2 Microglobulin 
[Units: Participants]
       
>5.5 mg/L   74   78   67   219 
<=5.5 mg/L   77   75   87   239 
Missing   1   0   0   1 
Albumin 
[Units: Participants]
       
>35 g/L   87   82   81   250 
<= 35 g/L   63   70   72   205 
Missing   2   1   1   4 
C-reactive Protein 
[Units: Participants]
       
>4 mg/L   65   56   64   185 
<=4 mg/L   84   94   89   267 
Missing   3   3   1   7 
Multiple Myeloma Subtype 
[Units: Participants]
       
Immunoglobulin A (IgA)   39   38   33   110 
Other   108   112   116   336 
Missing   5   3   5   13 
Plasma Cells in the Bone Marrow 
[Units: Percentage of plasma cells]
Mean (Standard Deviation)
 39.8  (24.79)   39.3  (25.01)   37.9  (23.65)   39.0  (24.45) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Kaplan Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Central Adjudication Committee (CAC)   [ Time Frame: up to 165 weeks ]

2.  Secondary:   Kaplan Meier Estimates of Progression-free Survival (PFS) From Start of Maintenance Therapy Period Based on the Response Assessment by the Central Adjudication Committee (CAC)   [ Time Frame: Approximately week 37 (start of cycle 10) to week 165 ]

3.  Secondary:   Kaplan Meier Estimates of Overall Survival (OS)   [ Time Frame: up to 177 weeks ]

4.  Secondary:   Kaplan Meier Estimates of Time to Progression (TTP) Based on the Response Assessment by the Central Adjudication Committee (CAC)   [ Time Frame: up to 165 weeks ]

5.  Secondary:   Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period   [ Time Frame: Up to 165 weeks ]

6.  Secondary:   Time to First Response   [ Time Frame: Up to 66 weeks ]

7.  Secondary:   Kaplan Meier Estimates for Duration of Response as Determined by the Central Adjudication Committee (CAC)   [ Time Frame: Up to 149 weeks ]

8.  Secondary:   Kaplan Meier Estimates for Time to Next Antimyeloma Therapy   [ Time Frame: Up to 168 weeks ]

9.  Secondary:   Summary of Participants With Treatment-Emergent Adverse Events (TEAE) During the Double-Blind Treatment Period   [ Time Frame: Up to 169 weeks (Double-blind therapy period plus 4 weeks) ]

10.  Secondary:   Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale   [ Time Frame: Baseline (Day 0), Months 4, 7, 10, 13, 16 ]

11.  Secondary:   Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale   [ Time Frame: Baseline (Day 0), Months 4, 7, 10, 13, 16 ]

12.  Secondary:   Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale   [ Time Frame: Baseline (Day 0), Months 4, 7, 10, 13, 16 ]

13.  Secondary:   Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale   [ Time Frame: Baseline (Day 0), Months 4, 7, 10, 13, 16 ]

14.  Secondary:   Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale   [ Time Frame: Baseline (Day 0), Months 4, 7, 10, 13, 16 ]

15.  Secondary:   Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale   [ Time Frame: Baseline (Day 0), Months 4, 7, 10, 13, 16 ]

16.  Secondary:   Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale   [ Time Frame: Baseline (Day 0), Months 4, 7, 10, 13, 16 ]

17.  Secondary:   Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea and Vomiting Scale   [ Time Frame: Baseline (Day 0), Months 4, 7, 10, 13, 16 ]

18.  Secondary:   Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale   [ Time Frame: Baseline (Day 0), Months 4, 7, 10, 13, 16 ]

19.  Secondary:   Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale   [ Time Frame: Baseline (Day 0), Months 4, 7, 10, 13, 16 ]

20.  Secondary:   Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale   [ Time Frame: Baseline (Day 0), Months 4, 7, 10, 13, 16 ]

21.  Secondary:   Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale   [ Time Frame: Baseline (Day 0), Months 4, 7, 10, 13, 16 ]

22.  Secondary:   Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale   [ Time Frame: Baseline (Day 0), Months 4, 7, 10, 13, 16 ]

23.  Secondary:   Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale   [ Time Frame: Baseline (Day 0), Months 4, 7, 10, 13, 16 ]

24.  Secondary:   Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Difficulties Scale   [ Time Frame: Baseline (Day 0), Months 4, 7, 10, 13, 16 ]

25.  Secondary:   Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale   [ Time Frame: Baseline (Day 0), Months 4, 7, 10, 13, 16 ]

26.  Secondary:   Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale   [ Time Frame: Baseline (Day 0), Months 4, 7, 10, 13, 16 ]

27.  Secondary:   Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale   [ Time Frame: Baseline (Day 0), Months 4, 7, 10, 13, 16 ]

28.  Secondary:   Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Body Image Scale   [ Time Frame: Baseline (Day 0), Months 4, 7, 10, 13, 16 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
phone: 1-888-260-1599
e-mail: clinicaltrialdisclosure@celgene.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00405756     History of Changes
Other Study ID Numbers: CC-5013-MM-015
2006-001865-41 ( EudraCT Number )
Study First Received: November 29, 2006
Results First Received: April 16, 2012
Last Updated: May 11, 2016
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Belarus: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Georgia: Ministry of Health
Greece: National Organization of Medicines
Ireland: Irish Medicines Board
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: The Italian Medicines Agency
Netherlands: Dutch Health Care Inspectorate
Poland: The Central Register of Clinical Trials
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Ukraine: Ministry of Health