VELCADE-Thalidomide-Dexamethasone (VTD) vs Thalidomide-Dexamethasone (TD) Incorporated Into Double Autotransplantation for Untreated Multiple Myeloma (MM)

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michele Cavo
• Collaborator: Janssen-Cilag S.p.A.
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Thalidomide

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.