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Trial record 21 of 494 for:    LENALIDOMIDE AND every 28 days

Pegylated Liposomal Doxorubicin, Bortezomib, Dexamethasone and Lenalidomide for Relapsed/Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT01160484
Recruitment Status : Completed
First Posted : July 12, 2010
Results First Posted : April 21, 2014
Last Update Posted : May 4, 2015
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Oncotherapeutics

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Intervention Drug: DVD-R
Enrollment 40
Recruitment Details This study enrolled patients from eight different clinical sites sites in the United States. Data was collected from September 2009 until July 25, 2011
Pre-assignment Details  
Arm/Group Title DVD-R Single Arm
Hide Arm/Group Description

Dose schematic of Dexamethasone + Bortezomib + Pegylated Liposomal Doxorubicin (PLD)+ Lenalidomide (DVD-R) Therapy:

Per 28 Day Cycle, patients will received drug in the following order, dosing and schedule:

1) Dexamethasone- 40 mg intravenous infusion (IV) on Days 1, 4, 8 and 11; 2) Bortezomib- 1.0 mg/m2 infused over 3 to 5 seconds followed by a standard saline flush on Days 1, 4, 8 and 11; 3) Pegylated Liposomal Doxorubicin- 4.0 mg/m2 IV as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle; and 4) Lenalidomide- 10 mg PO on days 1-14

Period Title: Overall Study
Started 40
Completed 22
Not Completed 18
Reason Not Completed
Lack of Efficacy             9
Adverse Event             6
Withdrawal by Subject             2
inclusion/exclusion criteria failure             1
Arm/Group Title DVD-R Single Arm
Hide Arm/Group Description

Dose schematic of Dexamethasone + Bortezomib + Pegylated Liposomal Doxorubicin + Lenalidomide (DVD-R) Therapy:

Per 28 Day Cycle, patients will received drug in the following order, dosing and schedule:

1) Dexamethasone- 40 mg intravenous infusion (IV) on Days 1, 4, 8 and 11; 2) Bortezomib- 1.0 mg/m2 infused over 3 to 5 seconds followed by a standard saline flush on Days 1, 4, 8 and 11; 3) Pegylated Liposomal Doxorubicin- 4.0 mg/m2 IV as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle; and 4) Lenalidomide- 10 mg PO on days 1-14

Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
The estimated number of participants will allow to determine whether the true rate of response to DVD-R is at least 50%, at the one-sided alpha-level of 0.05 and having at least 85% power
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
  32.5%
>=65 years
27
  67.5%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants
71
(34 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
15
  37.5%
Male
25
  62.5%
International Staging System (ISS); stage (N)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants
I (beta 2 microglobulin(B2M )<3.5 +Albumin ≥3.5) 16
II (B2M 3.5 +albumin < 3.5; or B2M 3.5–5.5) 14
III (B2M >5.5) 10
Serum M-protein  
Median (Full Range)
Unit of measure:  g/dL
Number Analyzed 40 participants
2.05
(0.0 to 7.0)
Urine-M protein  
Median (Full Range)
Unit of measure:  mg/dL
Number Analyzed 40 participants
261.1
(0.0 to 7162.0)
Serum creatinine  
Median (Full Range)
Unit of measure:  mg/dL
Number Analyzed 40 participants
1.0
(0.6 to 3.4)
Prior treatments  
Mean (Full Range)
Unit of measure:  Number of treatments
Number Analyzed 40 participants
3
(1 to 17)
Total Number of prior lines of treatment  
Measure Type: Number
Unit of measure:  Number of treatments
Number Analyzed 40 participants
Bortezomib (BTZ) 33
Alkylating agents 20
PLD or Doxorubucin 15
Thalidomide 15
Lenalidomide (LEN) 19
Glucocorticoids 35
HDAC inhibitors (panobinostat/romidepsin) 7
Transplant (autologous) 5
Other 11
PLD+btz+dexamethasone (dex) 17
PLD+btz+dex and len+ glucocorticoids 10
1.Primary Outcome
Title International Myeloma Working Group (IMWG) Response Criteria
Hide Description The investigator will evaluate each patient for response to therapy according to criteria augmented from those developed by Bladé et al., 1998 presented below (Table 7-1). Assessment of disease response will be performed prior to drug administration on Day 1 of Cycles 2 8 and at the End of Study Treatment visit. If a patient is determined to have complete response (CR), very good partial response (VGPR), partial response (PR), or minor response (MR), then assessment of disease response is to be performed 4 weeks later to confirm the response.
Time Frame Up to 7.5 months (eight 28-day cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
Population analysis was carried out as per protocol. Efficacy was evaluated via a modified version of the Bladé response criteria [complete response (CR), very good partial response (VGPR), partial response (PR), and those achieving minimal response (MR)]
Arm/Group Title DVD-R Single Arm
Hide Arm/Group Description:
40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: participants
CR 8
VGPR 4
PR 7
Objective Response (CR+VGPR+PR) 19
MR 14
Clinical Benefit (CR+VGPR+PR+MR) 33
Estable disease 4
Progressive disease 2
2.Secondary Outcome
Title Time to First Response
Hide Description [Not Specified]
Time Frame Up to 7.5 months (eight 28-day cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DVD-R Single Arm
Hide Arm/Group Description:
40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
Overall Number of Participants Analyzed 33
Median (Full Range)
Unit of Measure: months
1
(1 to 5)
3.Secondary Outcome
Title Time to Best Response
Hide Description [Not Specified]
Time Frame Up to 7.5 months (eight 28-day cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DVD-R Single Arm
Hide Arm/Group Description:
40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
Overall Number of Participants Analyzed 33
Median (Full Range)
Unit of Measure: months
2
(1 to 6)
4.Secondary Outcome
Title Duration of Response
Hide Description [Not Specified]
Time Frame First evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DVD-R Single Arm
Hide Arm/Group Description:
40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
Overall Number of Participants Analyzed 33
Median (Full Range)
Unit of Measure: months
12
(1 to 21)
5.Secondary Outcome
Title Time to Progression
Hide Description [Not Specified]
Time Frame Time from the start of treatment to progressive disease
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DVD-R Single Arm
Hide Arm/Group Description:
40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
Overall Number of Participants Analyzed 39
Median (Full Range)
Unit of Measure: months
9
(1 to 22)
6.Secondary Outcome
Title Progression-free Survival
Hide Description [Not Specified]
Time Frame Time from the start of treatment to progressive disease or until death
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DVD-R Single Arm
Hide Arm/Group Description:
40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
Overall Number of Participants Analyzed 39
Median (Full Range)
Unit of Measure: months
9
(1 to 22)
7.Secondary Outcome
Title Follow-up Time
Hide Description time that patients were monitored for disease progression and overall survival
Time Frame Follow-up visits for disease progression and overall survival every 3 months after study discontinuation. After progression, follow-up visits for survival status every 6 months or until alternate therapy needs to be started or death intervenes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DVD-R Single Arm
Hide Arm/Group Description:
40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
Overall Number of Participants Analyzed 39
Median (Full Range)
Unit of Measure: months
11
(2 to 22)
Time Frame Severity and frequency of adverse events (AEs) were evaluated at each visit. Serious adverse events (SAEs) were followed until resolution or until clearly determined be unrelated to study treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DVD-R Single Arm
Hide Arm/Group Description 40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
All-Cause Mortality
DVD-R Single Arm
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
DVD-R Single Arm
Affected / at Risk (%) # Events
Total   10/40 (25.00%)    
Gastrointestinal disorders   
Vomiting * 1  1/40 (2.50%)  1
Disphagia * 1  1/40 (2.50%)  1
General disorders   
Abdominal pain * 1  1/40 (2.50%)  1
Loss of balance * 1  1/40 (2.50%)  1
Immune system disorders   
Allergic reaction * 1  1/40 (2.50%)  1
Nervous system disorders   
Syncopal episode * 1  1/40 (2.50%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia * 1  5/40 (12.50%)  5
Upper respiratory infection * 1  1/40 (2.50%)  1
Dyspnea * 1  1/40 (2.50%)  1
Pulmonary emboli * 1  1/40 (2.50%)  1
Skin and subcutaneous tissue disorders   
Cellulitis * 1  1/40 (2.50%)  1
Vascular disorders   
Septic thrombophlebitis * 1  1/40 (2.50%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, NCI CTCAE V3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DVD-R Single Arm
Affected / at Risk (%) # Events
Total   23/40 (57.50%)    
Blood and lymphatic system disorders   
Neutropenia  1  14/40 (35.00%)  14
Thrombocytopenia  1  14/40 (35.00%)  14
Anemia  1  12/40 (30.00%)  12
Edema * 1  12/40 (30.00%)  12
Leukopenia  1  7/40 (17.50%)  7
Gastrointestinal disorders   
Diarrhea * 1  10/40 (25.00%)  10
Nausea * 1  10/40 (25.00%)  10
Abdominal pain * 1  5/40 (12.50%)  5
General disorders   
Fatigue * 1  16/40 (40.00%)  16
Generalized pain * 1  5/40 (12.50%)  5
Metabolism and nutrition disorders   
Hypocalcemia  1  8/40 (20.00%)  8
Hypokalemia  1  6/40 (15.00%)  6
Nervous system disorders   
Periphenal neurophaty  1  10/40 (25.00%)  10
Psychiatric disorders   
Confusion * 1  9/40 (22.50%)  9
Reproductive system and breast disorders   
Pelvic pain * 1  7/40 (17.50%)  7
Respiratory, thoracic and mediastinal disorders   
Upper respiratory infection * 1  12/40 (30.00%)  12
Cough * 1  6/40 (15.00%)  6
Pneumonia * 1  6/40 (15.00%)  6
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, NCI CTCAE V3.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Operations
Organization: Oncotherapeutics
Phone: 323-623-1200
EMail: lthulin@oncotherapeutics.com
Layout table for additonal information
Responsible Party: Oncotherapeutics
ClinicalTrials.gov Identifier: NCT01160484     History of Changes
Other Study ID Numbers: RV-MM-PI-0533
First Submitted: July 7, 2010
First Posted: July 12, 2010
Results First Submitted: January 10, 2014
Results First Posted: April 21, 2014
Last Update Posted: May 4, 2015