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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00405756
First received: November 29, 2006
Last updated: January 23, 2014
Last verified: January 2014
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
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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
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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  
Number of Participants  
[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  
International Staging System (ISS) [2]
[units: participants]
       
Stage I     28     32     28     88  
Stage II     50     47     48     145  
Stage III     74     74     78     226  
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  
[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.
[2] 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.



  Outcome Measures
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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
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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
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  More Information
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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


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Publications automatically indexed to this study:

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00405756     History of Changes
Other Study ID Numbers: CC-5013-MM-015, 2006-001865-41
Study First Received: November 29, 2006
Results First Received: April 16, 2012
Last Updated: January 23, 2014
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