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Report for Clinical Trial NCT01134484

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT01134484 Multiple Myeloma
MeSH:Multiple Myeloma Neoplasms, Plasma Cell
HPO:Multiple myeloma

6 Interventions

Name: Velcade

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)
Type: Drug
Group Labels: 1

VTD

Name: Thalidomide

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
Type: Drug
Group Labels: 2

TD VTD

Name: Dexamethasone

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)
Type: Drug
Group Labels: 2

TD VTD

Name: Peripheral Blood Stem Cell (PBSC) collection

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
Type: Procedure
Group Labels: 2

TD VTD

Name: First Autologous Transplantation

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
Type: Procedure
Group Labels: 2

TD VTD

Name: Second Autologous Transplantation

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
Type: Procedure
Group Labels: 2

TD VTD


Primary Outcomes

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.

Measure: Rate of CR+nCR to induction treatment

Time: 63 days after the start day of either TD or VTD as induction therapy

Secondary Outcomes

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.

Measure: Rate of CR+nCR to autotransplantation(s) and subsequent consolidation therapy

Time: 90 days after the second autologous transplantation and 70 days after the beginning of either TD or VTD as consolidation therapy

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.

Measure: Time To Progression (TTP)

Time: Average time period between the start day of either TD or VTD as induction therapy and the day of relapse or progression

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.

Measure: Progression-Free Survival (PFS)

Time: 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

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.

Measure: Overall Survival (OS)

Time: Average time period between the start day of either TD or VTD as induction therapy and the day of death, due to any cause

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.

Measure: Safety

Time: 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

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 G21210A

- Patient has a previous diagnosis of antiphospholipid antibodies or lupus anticoagulant, factor V Leiden mutation, prothrombin G21210A mutation, antithrombin, protein C or S deficiency. --- G21210A ---



HPO Nodes


HPO: