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Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00644228
First received: March 22, 2008
Last updated: June 6, 2017
Last verified: June 2017
Results First Received: April 20, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: DS Stage I Plasma Cell Myeloma
DS Stage II Plasma Cell Myeloma
DS Stage III Plasma Cell Myeloma
Interventions: Drug: Bortezomib
Drug: Dexamethasone
Other: Laboratory Biomarker Analysis
Drug: Lenalidomide

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I (Dexamethasone and Lenalidomide)

Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Dexamethasone: Given PO

Laboratory Biomarker Analysis: Optional correlative studies

Lenalidomide: Given PO

Arm II (Dexamethasone, Lenalidomide, Bortezomib)

Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

Bortezomib: Given IV

Dexamethasone: Given PO

Laboratory Biomarker Analysis: Optional correlative studies

Lenalidomide: Given PO


Participant Flow for 3 periods

Period 1:   Randomization & Eligibility
    Arm I (Dexamethasone and Lenalidomide)   Arm II (Dexamethasone, Lenalidomide, Bortezomib)
STARTED   261   264 
Eligible and Analyzable [1]   229   242 
COMPLETED [2]   229   242 
NOT COMPLETED   32   22 
Ineligible                31                21 
Withdrew Consent prior to therapy start                1                0 
Invalid Consent                0                1 
[1] All patients who were consented and did not withdraw consent prior to treatment are "Analyzable".
[2] "Completed" does not apply to this study period.

Period 2:   Induction Therapy
    Arm I (Dexamethasone and Lenalidomide)   Arm II (Dexamethasone, Lenalidomide, Bortezomib)
STARTED   229   242 
COMPLETED   146   137 
NOT COMPLETED   83   105 
Adverse Event                22                55 
Withdrawal by Subject                10                3 
Progression/Relapse                24                12 
Death                3                7 
Not Protocol-Specified                24                28 

Period 3:   Maintenance
    Arm I (Dexamethasone and Lenalidomide)   Arm II (Dexamethasone, Lenalidomide, Bortezomib)
STARTED   143 [1]   135 [2] 
COMPLETED [3]   0   0 
NOT COMPLETED   143   135 
Adverse Event                27                31 
Withdrawal by Subject                6                4 
Progression/Relapse                67                42 
Death                3                3 
Not Protocol-Specified                14                15 
On Treatment                26                40 
[1] 3 patients who completed induction did not continue on to maintenance due to refusal (1), other (2).
[2] 2 patients who completed induction did not continue on to maintenance due to other (2).
[3] Patients were treated until progression or removal/refusal. "Completed" does not apply.



  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.
Includes all eligible and analyzable patients.

Reporting Groups
  Description
Arm I (Dexamethasone and Lenalidomide)

Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Dexamethasone: Given PO

Laboratory Biomarker Analysis: Optional correlative studies

Lenalidomide: Given PO

Arm II (Dexamethasone, Lenalidomide, Bortezomib)

Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

Bortezomib: Given IV

Dexamethasone: Given PO

Laboratory Biomarker Analysis: Optional correlative studies

Lenalidomide: Given PO

Total Total of all reporting groups

Baseline Measures
   Arm I (Dexamethasone and Lenalidomide)   Arm II (Dexamethasone, Lenalidomide, Bortezomib)   Total 
Overall Participants Analyzed 
[Units: Participants]
 229   242   471 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      120  52.4%      149  61.6%      269  57.1% 
>=65 years      109  47.6%      93  38.4%      202  42.9% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      107  46.7%      89  36.8%      196  41.6% 
Male      122  53.3%      153  63.2%      275  58.4% 
ISS Stage [1] 
[Units: Participants]
Count of Participants
     
ISS Stage I or II      150  65.5%      164  67.8%      314  66.7% 
ISS Stage III      79  34.5%      78  32.2%      157  33.3% 
[1]

International Staging System (ISS) Criteria:

Stage I: Serum β2-microglobulin < 3.5mg/L and Serum Albumin ≥ 3.5 g/dL; expected median survival is 62 months. Stage II*: Not Stage I or III; expected median survival is 44 months. Stage III: Serum β2-microglobulin > 5.5 mg/L; expected median survival is 29 months.

*There are two categories for stage II: serum β2-microglobulin < 3.5 mg/L but serum albumin < 3.5 g/dL; or serum β2-microglobulin 3.5 to < 5.5 mg/L irrespective of the serum albumin level.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival   [ Time Frame: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 6 years ]

2.  Secondary:   Overall Survival   [ Time Frame: Up to 6 years ]

3.  Secondary:   Response Rates ()   [ Time Frame: Up to 6 years ]


  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
No text entered.


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623


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

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00644228     History of Changes
Other Study ID Numbers: NCI-2009-00798
NCI-2009-00798 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SWOG-S0777
CDR0000590321
S0777
S0777 ( Other Identifier: SWOG )
S0777 ( Other Identifier: CTEP )
U10CA180888 ( U.S. NIH Grant/Contract )
U10CA032102 ( U.S. NIH Grant/Contract )
Study First Received: March 22, 2008
Results First Received: April 20, 2017
Last Updated: June 6, 2017