Back to resultsVELCADE-Thalidomide-Dexamethasone (VTD) vs Thalidomide-Dexamethasone (TD) Incorporated Into Double Autotransplantation for Untreated Multiple Myeloma (MM)
Primary Purpose
Multiple Myeloma
Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Velcade
Thalidomide
Dexamethasone
Peripheral Blood Stem Cell (PBSC) collection
First Autologous Transplantation
Second Autologous Transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring autologous stem cell transplantation, complete remission, bortezomib, thalidomide, progression free survival, induction and consolidation therapy
Eligibility Criteria
Inclusion criteria:
- Confirmed diagnosis of symptomatic MM based on standard criteria.
- No prior or current systemic therapy for MM, including steroids.
- At least 18 years and less than 65 years of age.
- Presence of quantifiable M protein in serum (e.g. greater than 1 g/dL for IgG MM, greater than 0.5 g/dL of IgA or IgD MM) or urine (e.g. greater than 200 mg/day for BJ MM).
- Karnofsky performance status (PS) at least 60%.
- Willing and able to comply with the protocol requirements.
- Agreement from both male and female patients to follow the risk management program established for the prevention of pregnancy, including double methods for contraception and beta-HCG tests for women of childbearing potential and contraception for males.
- Adequate organ function, including heart, liver, kidney (serum creatinine less than 2 mg/dL)
- Platelet count at least 70 x 10/mcL and absolute neutrophil count at least 1 x 10/mcl
Exclusion criteria:
- Diagnosis of asymptomatic MM or of MGUS based on standard criteria.
- Diagnosis of non-secretory MM.
- Diagnosis of AL Amyloidosis.
- Prior or current systemic therapy for MM, including steroids (with exception of bisphosphonates).
- Patient has received other investigational drugs within 30 days before enrollment.
- Female subjects pregnant or breastfeeding
- Patient has Grade 2 or higher peripheral neuropathy (NCI criteria).
- Patient has a prior history of thrombosis or venous thromboembolism or pulmonary embolism.
- Patient has a previous diagnosis of antiphospholipid antibodies or lupus anticoagulant, factor V Leiden mutation, prothrombin G21210A mutation, antithrombin, protein C or S deficiency.
- Patient has a clear indication to receive a specific other anti-platelet therapy (e.g. clopidogrel, ticlopidine).
- Patient has a clear indication to receive long-term anticoagulant therapy (e.g. prosthetic heart valve, atrial fibrillation).
- Active bleeding or high risk of bleeding (gastrointestinal bleeding within the past 12 months; endoscopic diagnosis of peptic ulcer disease or ulcerative esophagitis within the past 6 months unless there is documented endoscopic evidence of healing; intracranial bleeding within the past year; amyloidosis; known bleeding diathesis).
- Seropositive for HIV, or active hepatitis A, B or C infection.
- Poorly controlled hypertension or diabetes mellitus (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before the start of therapy) or other serious medical or psychiatric conditions that could interfere with adherence to or completion of this study.
- Patient has hypersensitivity to bortezomib, boron or mannitol.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Previous or concurrent malignancies at other sites, with the exception of appropriately treated localized epithelial skin or cervical cancer. Patients with remote histories (>5 years) of other cured tumors may be entered.
- Receipt of extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks before enrolment.
Sites / Locations
- AOU di Bologna Policlinico S.Orsola-Malpighi, UO di Ematologia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VTD
TD
Arm Description
Outcomes
Primary Outcome Measures
Rate of CR+nCR to induction treatment
Responses to induction therapy were reported by study investigators and centrally reassessed by study coordinator(s). Criteria are those initially proposed by the European Group for Blood and Marrow Transplantation (EBMT), with the addition of nCR (100% M-protein reduction by electrophoresis, but immunofixation-positive) and very good partial response (VGPR) (at least 90% serum and urine M-protein reduction) categories. Comparisons of response rates between treatment arms are performed using Fisher's exact test.
Secondary Outcome Measures
Rate of CR+nCR to autotransplantation(s) and subsequent consolidation therapy
Responses to autotransplantation(s) and consolidation therapy were reported by study investigators and centrally reassessed by study coordinator(s). Criteria are those initially proposed by the EBMT, with the addition of nCR and VGPR categories. Comparisons of response rates between treatment arms are performed using Fisher's exact test. Comparisons of response rates between treatment arms are performed using Fisher's exact test.
Time To Progression (TTP)
TTP is defined as time from start of induction treatment with either TD or VTD to relapse or progression, as evaluated according to EBMT criteria. Comparison of TTP between treatment arms is performed using the log-rank test; distributions are estimated using Kaplan-Meier methodology.
Progression-Free Survival (PFS)
PFS is defined as time from start of treatment to progression/relapse, or death, whichever occurs firstly. Comparison of PFS between treatment arms is performed using the log-rank test; distributions are estimated using Kaplan-Meier methodology.
Overall Survival (OS)
OS is defined as time from start of treatment to death. Comparison of OS between treatment arms is performed using the log-rank test; distributions are estimated using Kaplan-Meier methodology.
Safety
Safety is monitored until 30 days after the last dose of study drug. Toxicities are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. Rates of adverse events are compared between treatment arms using the chi-square test.
Full Information
NCT ID
NCT01134484
First Posted
May 28, 2010
Last Updated
July 19, 2012
Sponsor
Michele Cavo
Collaborators
Janssen-Cilag S.p.A.
1. Study Identification
Unique Protocol Identification Number
NCT01134484
Brief Title
VELCADE-Thalidomide-Dexamethasone (VTD) vs Thalidomide-Dexamethasone (TD) Incorporated Into Double Autotransplantation for Untreated Multiple Myeloma (MM)
Official Title
A Phase 3, Prospective, Randomized Clinical Study of VELCADE-Thalidomide-Dexamethasone (VTD) Versus Thalidomide-Dexamethasone (TD) for Previously Untreated Multiple Myeloma (MM) Patients Who Are Candidates to Receive Double Autologous Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michele Cavo
Collaborators
Janssen-Cilag S.p.A.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Thalidomide-Dexamethasone (TD) is a standard induction therapy for Multiple Myeloma (MM). The present study is designed to compare TD with VELCADE-Thalidomide-Dexamethasone (VTD) as induction therapy in preparation for, and as consolidation after, melphalan-based double autologous stem cell transplantation for previously untreated patients aged ≤65 years with symptomatic MM. Primary study endpoint is the rate of complete response (CR) plus near-complete response (nCR) to induction treatment. Secondary endpoints include the rate of CR plus nCR to double transplantation and subsequent consolidation therapy, time to progression (TTP), progression-free survival (PFS),overall survival (OS) and toxicity profile of both VTD and TD.
Detailed Description
This prospective phase 3 trial is aimed at evaluating whether, in comparison with standard TD, addition of Velcade to TD increases rate of CR and nCR from 15% to 30%, respectively. For this purpose, symptomatic patients aged 18-65 years with previously untreated MM and quantifiable M-protein in serum or urine are randomized (1:1) to receive induction therapy comprising three 3-week cycles of Velcade 1.3 mg/sqm, days 1, 4, 8, 11, thalidomide 100 mg, days 1-14, cycle 1, then 200 mg daily, and dexamethasone 40 mg, days 1, 2, 4, 5, 8, 9, 11, 12, or thalidomide and dexamethasone (same schedule and dosage as in VTD). Randomization to VTD or TD is stratified according to International Staging System disease stage at diagnosis. Following induction therapy, patients in both arms receive cyclophosphamide (4 g/sqm, day 0 and granulocyte colony-stimulating factor, 10 μcg/kg/day, from day +2) to collect autologous peripheral blood stem cells (minimum threshold CD34+ cells: 4 x 10^6/kg) and two subsequent courses of stem cell-supported high dose melphalan (200 mg/sqm), 3 to 6 months apart. Upon neutrophil (≥1 x 10^9/L) and platelet (≥75 x 10^9/L) recovery following the first autotransplantation, patients receive thalidomide (100 mg daily) and dexamethasone (40 mg, days 1-4 every 4 weeks) as bridge therapy until the day before the second transplantation.
Patients initially randomized to receive VTD or TD induction therapy are planned to receive two 5-week cycles of VTD (Velcade 1.3 mg/sqm, days 1, 8, 15, 22; thalidomide 100 mg daily; dexamethasone 40 mg, days 1, 2, 8, 9, 15, 16, 22, 23) or TD (thalidomide 100 mg daily; dexamethasone 40 mg, days 1-4 and 20-23) as consolidation therapy, starting 3 months after last transplant. Maintenance therapy comprise dexamethasone 40 mg, days 1-4, repeated monthly until relapse or progression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
autologous stem cell transplantation, complete remission, bortezomib, thalidomide, progression free survival, induction and consolidation therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VTD
Arm Type
Experimental
Arm Title
TD
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Velcade
Other Intervention Name(s)
Bortezomib
Intervention Description
INDUCTION THERAPY: 1.3 mg/sqm as a bolus i.v. injection on days 1, 4, 8 and 11 (3 courses, 21 days each)
REMISSION CONSOLIDATION THERAPY: 1.3 mg/sqm as a bolus i.v. injection on days 1, 8, 15 and 22 (2 courses, 35 days each)
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Other Intervention Name(s)
Talidomide
Intervention Description
INDUCTION THERAPY: 100 mg/d on days 1-14, 200 mg/d on days 15-63 (in case of delay of HD-CTX , Thalidomide will be continued until the day before Cyclophosphamide as priming therapy for PBSC collection)
AFTER PBSC COLLECTION: 100 mg/d from day after last PBSC collection until the day before first course of MEL-200
AFTER FIRST TRANSPLANTATION: 100 mg/d from recovery of hematopoiesis until the day before the second course of MEL-200
REMISSION CONSOLIDATION THERAPY (starting 3 months after the second autologous transplantation): 100 mg/d days 1-70
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Soldesam
Intervention Description
INDUCTION THERAPY
VTD ARM: 40 mg/d days 1-2, 4-5, 8-9 and 11-12 (3 cycles, 21 days each)
TD ARM: 40 mg/d days 1-4 and 9-12 (3 cycles, 21 days each)
AFTER PBSC COLLECTION: 40 mg/d for 4 days (starting the same day of resumption of Thalidomide)
AFTER FIRST TRANSPLANTATION: 40 mg/d for 4 days (starting the same day of resumption of Thalidomide) and repeated every 28 days, for 3 months
REMISSION CONSOLIDATION THERAPY (starting 3 months after the second autologous transplantation)
VTD ARM: 40 mg/d days 1-2, 8-9, 15-16 and 22-23 (2 cycles, 35 days each)
TD ARM: 40 mg/d days 14 and 20-23 (2 cycles, 35 days each)
Intervention Type
Procedure
Intervention Name(s)
Peripheral Blood Stem Cell (PBSC) collection
Intervention Description
Cyclophosphamide (CTX): 4 g/sqm given in a single day (day 0)
G-CSF: 10 µcg/kg/d, starting on day +2 from CTX and continuing until completion of PBSC collection
Intervention Type
Procedure
Intervention Name(s)
First Autologous Transplantation
Intervention Description
HIGH-DOSE MELPHALAN (MEL-200): 200 mg/sqm, given as a single dose i.v. (day -2) followed by PBSC infusion 48 hours later (day 0)
G-CSF: 5 µcg/kg daily starting from day +6 after grafting and continuing until the patient's ANC is more than 0.5x10^9/L for 3 consecutive days
Intervention Type
Procedure
Intervention Name(s)
Second Autologous Transplantation
Intervention Description
HIGH-DOSE MELPHALAN (MEL-200): 200 mg/sqm, given as a single dose i.v. (day -2) followed by PBSC infusion 48 hours later (day 0)
G-CSF: 5 µcg/kg daily starting from day +6 after grafting and continuing until the patient's ANC is more than 0.5x10^9/L for 3 consecutive days
Primary Outcome Measure Information:
Title
Rate of CR+nCR to induction treatment
Description
Responses to induction therapy were reported by study investigators and centrally reassessed by study coordinator(s). Criteria are those initially proposed by the European Group for Blood and Marrow Transplantation (EBMT), with the addition of nCR (100% M-protein reduction by electrophoresis, but immunofixation-positive) and very good partial response (VGPR) (at least 90% serum and urine M-protein reduction) categories. Comparisons of response rates between treatment arms are performed using Fisher's exact test.
Time Frame
63 days after the start day of either TD or VTD as induction therapy
Secondary Outcome Measure Information:
Title
Rate of CR+nCR to autotransplantation(s) and subsequent consolidation therapy
Description
Responses to autotransplantation(s) and consolidation therapy were reported by study investigators and centrally reassessed by study coordinator(s). Criteria are those initially proposed by the EBMT, with the addition of nCR and VGPR categories. Comparisons of response rates between treatment arms are performed using Fisher's exact test. Comparisons of response rates between treatment arms are performed using Fisher's exact test.
Time Frame
90 days after the second autologous transplantation and 70 days after the beginning of either TD or VTD as consolidation therapy
Title
Time To Progression (TTP)
Description
TTP is defined as time from start of induction treatment with either TD or VTD to relapse or progression, as evaluated according to EBMT criteria. Comparison of TTP between treatment arms is performed using the log-rank test; distributions are estimated using Kaplan-Meier methodology.
Time Frame
Average time period between the start day of either TD or VTD as induction therapy and the day of relapse or progression
Title
Progression-Free Survival (PFS)
Description
PFS is defined as time from start of treatment to progression/relapse, or death, whichever occurs firstly. Comparison of PFS between treatment arms is performed using the log-rank test; distributions are estimated using Kaplan-Meier methodology.
Time Frame
Average time period between the start day of either TD or VTD as induction therapy and the day of relapse or progression or death, whichever occurs firstly
Title
Overall Survival (OS)
Description
OS is defined as time from start of treatment to death. Comparison of OS between treatment arms is performed using the log-rank test; distributions are estimated using Kaplan-Meier methodology.
Time Frame
Average time period between the start day of either TD or VTD as induction therapy and the day of death, due to any cause
Title
Safety
Description
Safety is monitored until 30 days after the last dose of study drug. Toxicities are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. Rates of adverse events are compared between treatment arms using the chi-square test.
Time Frame
Average time period between the start day of either TD or VTD as induction therapy and the day of any toxicity/adverse event(s) recorded during and after study drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Confirmed diagnosis of symptomatic MM based on standard criteria.
No prior or current systemic therapy for MM, including steroids.
At least 18 years and less than 65 years of age.
Presence of quantifiable M protein in serum (e.g. greater than 1 g/dL for IgG MM, greater than 0.5 g/dL of IgA or IgD MM) or urine (e.g. greater than 200 mg/day for BJ MM).
Karnofsky performance status (PS) at least 60%.
Willing and able to comply with the protocol requirements.
Agreement from both male and female patients to follow the risk management program established for the prevention of pregnancy, including double methods for contraception and beta-HCG tests for women of childbearing potential and contraception for males.
Adequate organ function, including heart, liver, kidney (serum creatinine less than 2 mg/dL)
Platelet count at least 70 x 10/mcL and absolute neutrophil count at least 1 x 10/mcl
Exclusion criteria:
Diagnosis of asymptomatic MM or of MGUS based on standard criteria.
Diagnosis of non-secretory MM.
Diagnosis of AL Amyloidosis.
Prior or current systemic therapy for MM, including steroids (with exception of bisphosphonates).
Patient has received other investigational drugs within 30 days before enrollment.
Female subjects pregnant or breastfeeding
Patient has Grade 2 or higher peripheral neuropathy (NCI criteria).
Patient has a prior history of thrombosis or venous thromboembolism or pulmonary embolism.
Patient has a previous diagnosis of antiphospholipid antibodies or lupus anticoagulant, factor V Leiden mutation, prothrombin G21210A mutation, antithrombin, protein C or S deficiency.
Patient has a clear indication to receive a specific other anti-platelet therapy (e.g. clopidogrel, ticlopidine).
Patient has a clear indication to receive long-term anticoagulant therapy (e.g. prosthetic heart valve, atrial fibrillation).
Active bleeding or high risk of bleeding (gastrointestinal bleeding within the past 12 months; endoscopic diagnosis of peptic ulcer disease or ulcerative esophagitis within the past 6 months unless there is documented endoscopic evidence of healing; intracranial bleeding within the past year; amyloidosis; known bleeding diathesis).
Seropositive for HIV, or active hepatitis A, B or C infection.
Poorly controlled hypertension or diabetes mellitus (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before the start of therapy) or other serious medical or psychiatric conditions that could interfere with adherence to or completion of this study.
Patient has hypersensitivity to bortezomib, boron or mannitol.
Serious medical or psychiatric illness likely to interfere with participation in this clinical study
Previous or concurrent malignancies at other sites, with the exception of appropriately treated localized epithelial skin or cervical cancer. Patients with remote histories (>5 years) of other cured tumors may be entered.
Receipt of extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks before enrolment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Cavo, MD
Organizational Affiliation
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOU di Bologna Policlinico S.Orsola-Malpighi, UO di Ematologia
City
Bologna
ZIP/Postal Code
40138
Country
Italy
12. IPD Sharing Statement
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VELCADE-Thalidomide-Dexamethasone (VTD) vs Thalidomide-Dexamethasone (TD) Incorporated Into Double Autotransplantation for Untreated Multiple Myeloma (MM)
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