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Lenalidomide/Bortezomib/Dexamethasone for Multiple Myeloma (MM) (RVD Lite)

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ClinicalTrials.gov Identifier: NCT01782963
Recruitment Status : Completed
First Posted : February 4, 2013
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Noopur Raje, Massachusetts General Hospital

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Lenalidomide
Drug: Bortezomib
Drug: Dexamethasone

  Participant Flow

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
Treatment Arm

Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)

Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15

Lenalidomide

Bortezomib

Dexamethasone


Participant Flow:   Overall Study
    Treatment Arm
STARTED   50 
COMPLETED   50 
NOT COMPLETED   0 



  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
Treatment Arm

Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)

Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15

Lenalidomide

Bortezomib

Dexamethasone


Baseline Measures
   Treatment Arm 
Overall Participants Analyzed 
[Units: Participants]
 50 
Age 
[Units: Years]
Median (Full Range)
 73 
 (65 to 91) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      27  54.0% 
Male      23  46.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
White      42  84.0% 
Black or African-American      2   4.0% 
Asian      3   6.0% 
Other      3   6.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   50 
ISS Stage at Diagnosis [1] 
[Units: Participants]
Count of Participants
 
    19  38.0% 
II      17  34.0% 
III      14  28.0% 
[1]

International Staging System for Multiple Myeloma, divides multiple myeloma into three categories with III representing more advanced disease and I less advanced disease

Stage I :

  • Serum beta-2 microglobulin is less than 3.5 mg/L
  • AND Albumin level is 3.5 g/dL or greater
  • AND Cytogenetics are considered "not high risk"
  • AND Lactate dehydrogenase (LDH) levels are normal

Stage II: Not stage I or stage II

Stage III:

  • Serum beta-2 microglobulin is 5.5 (mg/L) or greater
  • AND Cytogenetics are considered “high-risk”
  • AND/OR LDH levels are high
Durie-Salmon Stage [1] 
[Units: Participants]
Count of Participants
 
    16  32.0% 
II      16  32.0% 
III      18  36.0% 
[1]

Stage III represents more advanced disease and stage I less advanced.

Stage I:

  • Hemoglobin value 10 g/dL
  • Serum calcium value normal or =12 mg/dL
  • Bone x-ray, normal bone structure (scale 0) or solitary bone plasmacytoma only
  • Low M-component production rate (IgG value <5 g/dL; IgA value <3 g/dL; Bence Jones protein <4 g/24 hr)

Stage II:

Neither stage I nor stage III

Stage III:

On or more of the following:

  • Hemoglobin value 12 mg/dL
  • Advanced lytic bone lesions (scale 3)
  • High M-component production rate – IgG value >7 g/dL; IgA value>5 g/dL; Bence Jones protein >12 g/24 h
ECOG Performance Status [1] 
[Units: Participants]
Count of Participants
 
    25  50.0% 
    18  36.0% 
    7  14.0% 
    0   0.0% 
    0   0.0% 
    0   0.0% 
[1]

The Eastern Cooperative Oncology Group (ECOG) Performance Status Score

  • 0: Asymptomatic (Fully active, no restrictions in self care)
  • 1: Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature)
  • 2: Symptomatic, <50% time in bed during the day (Ambulatory and capable of all self care but unable to carry out any work activities)
  • 3: Symptomatic, >50% time in bed during waking hours (Capable of only limited self-care)
  • 4: Bedbound (Completely disabled. Cannot carry on any self-care)
  • 5: Death
High-Risk Cytogenetics [1] 
[Units: Participants]
Count of Participants
 
Yes      6  12.0% 
No      42  84.0% 
Unknown      2   4.0% 
[1] Cytogenetics risk is determined by doing a genetic analysis of the participants bone marrow. The participants chromosomes are assessed for things like translocations (rearrangement of non-homologous chromosomes) or deletions (part of the genetic sequence is lost). Participants were considered high-risk if they had certain specific genetic changes. Translocations are noted as t(chromosome 1; chromosome 2) where the two chromosomes represent which non homologous chromosomes swapped genetic material. The high-risk cytogenetics included a deletion on chromosome 17, t(4;14), t(14;16), and t(14;20).
Serum Heavy/Light Chain [1] 
[Units: Participants]
Count of Participants
 
IgG      34  68.0% 
IgA      9  18.0% 
Light-chain only      5  10.0% 
Unknown      2   4.0% 
[1] The serum heavy/light chain immunoassay quantifies the light chain types of each immunoglobulin (Ig) class based on a sample of the participants blood. Typical antibodies consist of two Ig heavy chains connected to two Ig light chains. When the plasma cells become cancerous, it can result in an increase in monoclonal immunoglobulin in the blood serum. This is used as a measure of the tumor load. The information below gives which specific monoclonal immunoglobulin was detected.
Body Mass Index (BMI) 
[Units: Kg/m^2]
Median (Full Range)
 28 
 (18 to 45) 


  Outcome Measures

1.  Primary:   Objective Response Rate   [ Time Frame: 2 years ]

2.  Secondary:   Number of Participants With Grade 3 or Higher Treatment Related Adverse Events   [ Time Frame: 2 years ]

3.  Secondary:   Median Progression Free Survival   [ Time Frame: From the start of treatment until death or progression or until 3 years after the last participant is enrolled ]

4.  Secondary:   Median Overall Survival   [ Time Frame: From the start of treatment until death or until 5 years after the time of disease progression ]

5.  Secondary:   Mean Plasma Bortezomib Concentration Following Intravenous and and Subcutaneous Injection   [ Time Frame: Day 1 (5 min, 30min, 5 hours post dose), Days 8, 15, Day 22 (pre dose and 5 min, 30 min, 5 hrs post dose), cycle 2 day 1 pre dose ]

6.  Secondary:   Median Time to Response   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   06/2018  

7.  Secondary:   Response Rate With Respect to Cytogenetic Characteristics   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   06/2018  

8.  Secondary:   Evaluate Pharmacogenomic Markers   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   06/2018  


  Serious Adverse Events


  Other Adverse Events


  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

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Noopur Raje, MD
Organization: Massachusetts General Hospital
phone: 617-724-4000
e-mail: NRAJE@mgh.harvard.edu



Responsible Party: Noopur Raje, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01782963     History of Changes
Other Study ID Numbers: 12-498
First Submitted: January 15, 2013
First Posted: February 4, 2013
Results First Submitted: January 26, 2018
Results First Posted: March 13, 2018
Last Update Posted: March 13, 2018