Phase II Study of Velcade, Decadron, and Doxil Followed by Cyclophosphamide in Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00148317|
Recruitment Status : Completed
First Posted : September 7, 2005
Results First Posted : July 18, 2017
Last Update Posted : July 18, 2017
PRIMARY STUDY OBJECTIVES
To evaluate the efficacy of the combination of bortezomib, dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as a therapy for two different subsets of multiple myeloma patients:
- Patients post first line therapy
- Patients with relapsed/refractory disease who are bortezomib-naïve
- To evaluate the safety of the combination of bortezomib and dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as therapy for patients with multiple myeloma.
SECONDARY STUDY OBJECTIVES
- To evaluate the role of the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide on the ability to collect > 10 x 106 CD34+ cells/kg in < 7 collections (for both subsets of multiple myeloma patients).
- To evaluate the survival of patients who receive the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide (for both subsets of patients).
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Bortezomib Drug: dexamethasone Drug: liposomal doxorubicin Drug: cyclophoshamide Drug: filgrastim||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
Consolidation: All patients will receive 2 cycles of bortezomib (VEL) and dexamethasone (DEX). Patients who achieve a complete response after 2 cycles will receive 4 additional cycles of VEL/DEX before mobilization.
Patients who do not achieve at least a partial response after 2 cycles will receive 4 more cycles of VEL/DEX plus DOXIL.
Patients who achieve a partial response after 2 cycles on VEL/DEX, will continue this combination for 2 more cycles. Patients who achieve a complete response after 4 cycles will receive 2 additional cycles of VEL/DEX before mobilization. Patients who remain with a partial response after 4 cycles of VEL/DEX will receive 2 additional cycles of the combination of VEL/DEX plus DOXIL.
Mobilization: Patients who complete 6 cycles of consolidation will proceed to mobilization. Patients will receive one cycle of VEL plus high dose CYTOXAN followed by G-CSF beginning 24 hours after CYTOXAN given for a total of 10 daily doses.
|Masking:||None (Open Label)|
|Official Title:||A Sequential Phase II Trial of the Combination of Bortezomib (VELCADE), Dexamethasone (DECADRON) and Pegylated Liposomal Doxorubicin (DOXIL) Followed by High Dose Cyclophosphamide in Multiple Myeloma Patients|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||November 2012|
|Experimental: Treatment Arm||
During Induction Phase (6 cycles): Bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11 During 21-day mobilization cycle (1 cycle): Bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11
Other Name: velcadeDrug: dexamethasone
During Induction Phase (6 cycles): dexamethasone 40 mg on days 1-4, 8-11, and 15-18
Other Name: decadronDrug: liposomal doxorubicin
If patients achieve less then a PR during the induction phase after 2 cycles, or less then a CR after 4 cycles: Liposomal doxorubicin was added at 30 mg/m2 on day 4 for the remaining cyclesDrug: cyclophoshamide
During the 21 day mobilization phase (1 cycle): cyclophosphamide at 3 g/m2 on day 8
Other Name: cytoxanDrug: filgrastim
During the 21 day mobilization phase (1 cycle): 10 μg/kg/day for 10 consecutive days starting 24 hours after cyclophosphamide administration on day 9
Other Name: neupogen
- Efficacy of Drug Combination as Therapy for Myeloma (Overall Response Rate) [ Time Frame: Best response at any point during each respective study phase was collected - once after consolidation/prior to mobilization (approximately 6 cycles after start of treatment), and once after mobilization ]Myeloma response criteria developed by Bladé et al. was used to categorize response.
- Yield of CD34+ Stem Cells [ Time Frame: Occurred after mobilization, and prior to Stem cell transplant; a 7 day limit was imposed on stem cell collection ]This is the yield of CD34+ stem cells collection after high dose cyclophosphamide.
- Progression Free Survival [ Time Frame: Date of progression, assessed from start of trial to Final data cut off date (15 April 2011) ]
Response was assessed using IMWG guidelines, which for progressive disease are as follows:
Increase of > 25% from lowest response value in any one or more of the following:
- Serum M-component and/or (the absolute increase must be > 0.5 g/dL)*
- Urine M-component and/or (the absolute increase must be > 200 mg/24 h)
- Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL
- Bone marrow plasma cell percentage; the absolute percentage must be > 10%
- Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas
- Development of hypercalcaemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder IF starting M protein component is > 5g/dL, then absolute increase of 1g is sufficient for progression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00148317
|United States, New York|
|Weill Medical College of Cornell University|
|New York, New York, United States, 10021|
|Principal Investigator:||Ruben Niesvizky, MD||Weill Medical College of Cornell University|