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Combination Study of Revlimid®, Velcade® Dexamethasone and Doxil® (RVDD)for Newly Diagnosed Multiple Myeloma (RVDD)

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ClinicalTrials.gov Identifier: NCT00724568
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : September 10, 2014
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

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
Drug: Doxil
Enrollment 74
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase I Phase II
Hide Arm/Group Description Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles. Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
Period Title: Overall Study
Started 42 32
Completed 42 32
Not Completed 0 0
Arm/Group Title Combination Drug Therapy
Hide Arm/Group Description Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
Overall Number of Baseline Participants 72
Hide Baseline Analysis Population Description
A total of 74 patients were enrolled in this phase 1/2 study. 2 patients were not evaluable for the Dose Limiting Toxicity (DLT) and therefore only 72 are included in the baseline analysis population.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 72 participants
59
(29 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
Female
31
  43.1%
Male
41
  56.9%
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of Combination Therapy With VELCADE, Dexamethasone, and Doxil, (RVDD)
Hide Description

Dose Level 1:

15 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 20 mg/m2 Doxil daily on day 4

Dose Level 2:

20 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 20 mg/m2 Doxil daily on day 4

Dose Level 3:

25 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 20 mg/m2 Doxil daily on day 4

Dose Level 4:

25 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 30 mg/m2 Doxil daily on day 4

Time Frame 1 month post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 74 patients were enrolled in this phase 1/2 study: 42 in phase 1.
Arm/Group Title Combination Drug Therapy
Hide Arm/Group Description:
Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: mg
Revlimid 25
VELCADE 1.3
Dexamethasone 20
Doxil 30
2.Secondary Outcome
Title The Percentage of Patients That Achieved Partial or Complete Response to Treatment.
Hide Description

Partial Response:

  • 50% reduction in the level of serum monoclonal protein for at least two determinations six weeks apart.
  • If present, reduction in 24-hour urinary light chain excretion by either, greater than or equal to 90%, or to <200 mg for at least two determinations six weeks apart.
  • 50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for at least six weeks.
  • No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).

Complete Response:

  • Disappearance of the original monoclonal protein from the blood and urine on at least two determinations for a minimum of six weeks.
  • <5% plasma cells in the bone marrow on at least two determinations for a minimum of six weeks.
  • No increase in the size or number of lytic bone lesions.
Time Frame 24 weeks (8, 21-day cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
74 patients were enrolled, but 2 were not evaluable for dose limiting toxicities. 72 patients were included in this analysis.
Arm/Group Title Combination Drug Therapy
Hide Arm/Group Description:
Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
Overall Number of Participants Analyzed 72
Measure Type: Number
Unit of Measure: percentage of patients
96
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were captured collectively for the study, not by arm, because both arms received the same drugs.
 
Arm/Group Title Combination Drug Therapy
Hide Arm/Group Description Patients will be treated with Velcade at 1.3 mg/m2 on days 1, 4, 8, and 11, Doxil at indicated doses on day 4, Dexamethasone at 20 mg orally on days of Velcade and the day after for all dose levels, and Revlimid at indicated doses on days 1-14 in 3-week cycles for 4-8 cycles.
All-Cause Mortality
Combination Drug Therapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Combination Drug Therapy
Affected / at Risk (%) # Events
Total   3/74 (4.05%)    
Infections and infestations   
Pneumonia with Grade 3 or 4 Neutropenia  1/74 (1.35%)  1
Pneumonia with Normal Absolute Neutrophil Count  1/74 (1.35%)  1
Respiratory, thoracic and mediastinal disorders   
Lung Hemorrhage  1/74 (1.35%)  1
Pneumonitis  1/74 (1.35%)  1
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Combination Drug Therapy
Affected / at Risk (%) # Events
Total   24/74 (32.43%)    
Blood and lymphatic system disorders   
Anemia  10/74 (13.51%)  22
Leukocytes (total WBC)  6/74 (8.11%)  11
Lymphopenia  5/74 (6.76%)  12
Neutrophils/granulocytes (ANC/AGC)  4/74 (5.41%)  5
Platelets  6/74 (8.11%)  12
Gastrointestinal disorders   
Constipation  10/74 (13.51%)  14
Diarrhea  6/74 (8.11%)  12
Nausea  10/74 (13.51%)  11
Taste alteration (dysgeusia)  4/74 (5.41%)  6
General disorders   
Fatigue (asthenia, lethargy, malaise)  17/74 (22.97%)  32
Edema: limb  6/74 (8.11%)  6
Metabolism and nutrition disorders   
ALT, SGPT (serum glutamic pyruvic transaminase)  6/74 (8.11%)  9
Albumin, serum-low (hypoalbuminemia)  5/74 (6.76%)  9
Calcium, serum-low (hypocalcemia)  6/74 (8.11%)  12
Glucose, serum-high (hyperglycemia)  4/74 (5.41%)  8
Phosphate, serum-low (hypophosphatemia)  4/74 (5.41%)  9
Potassium, serum-low (hypokalemia)  5/74 (6.76%)  6
Sodium, serum-low (hyponatremia)  5/74 (6.76%)  5
Nervous system disorders   
Dizziness  7/74 (9.46%)  7
Mood alteration  5/74 (6.76%)  5
Neuropathy: sensory  7/74 (9.46%)  15
Pain  4/74 (5.41%)  5
Respiratory, thoracic and mediastinal disorders   
Cough  7/74 (9.46%)  9
Dyspnea (shortness of breath)  6/74 (8.11%)  7
Skin and subcutaneous tissue disorders   
Rash/desquamation  5/74 (6.76%)  5
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Moshe Talpaz
Organization: University of Michigan Comprehensive Cancer Center
Phone: 734-764-8195
EMail: mtalpaz@umich.edu
Layout table for additonal information
Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT00724568     History of Changes
Other Study ID Numbers: UMCC 2007.098
HUM 12962 ( Other Identifier: University of Michigan IRBMED )
First Submitted: April 11, 2008
First Posted: July 29, 2008
Results First Submitted: September 3, 2014
Results First Posted: September 10, 2014
Last Update Posted: June 2, 2017