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IT'S THE MOMENT OF TRUTH.
Will you tell your patients with multiple myeloma that if they responded to VELCADE® (bortezomib) before, retreatment can offer an additional benefit?

When considering a treatment sequence, choose VELCADE first. Learn more

For previously untreated multiple myeloma,
VELCADE (bortezomib)+MP provided an OS advantage over MP that was not regained with subsequent therapies (3-year median follow-up)

  • Median overall survival (OS) of 56.4 months for VELCADE (bortezomib)+MP vs median OS of 43.1 months for MP (HR=0.695 [95% CI, 0.57-0.85]; p<0.05; 60.1-month median follow-up)
  • Results achieved using twice-weekly followed by weekly dosing for a median of 50 weeks (54 weeks planned)1
  • The most commonly reported adverse reactions (ARs) were thrombocytopenia (48% vs 42%), neutropenia (47% vs 42%), peripheral neuropathy (46% vs 1%), nausea (39% vs 21%), diarrhea (35% vs 6%), neuralgia (34% vs <1%) anemia (32% vs 46%), and leukopenia (32% vs 28%)
  • A total of 25% of patients in the treatment group receiving VELCADE+MP experienced serious adverse reactions (ARs) vs 18% in the treatment group receiving MP. The most commonly reported serious ARs with VELCADE+MP vs MP alone included pneumonia (5% vs 4%), diarrhea (4% vs 0%), thrombocytopenia (3% vs 1%), vomiting (3% vs <1%), nausea (2% vs <1%), anemia (2% vs 2%), herpes zoster (2% vs <1%), and dehydration (2% vs <1%)2

When considering a treatment sequence, choose VELCADE first. Learn more

Retreatment with VELCADE (bortezomib)
±dexamethasone delivered a 6.5-month median duration of response (DOR) in patients who achieved at least a PR on a VELCADE-containing regimen and progressed ≥6 months after completing that regimen

  • 38.5% ORR (95% CI, 30.1-47.4; 49/50 achieved a PR)
  • VELCADE (bortezomib) treatment may be started at the last tolerated
    dose (±dexamethasone)
  • No cumulative toxicities were observed with VELCADE retreatment
  • The most common adverse drug reactions were thrombocytopenia, which occurred in 52% of patients (grade ≥3: 24%), and peripheral neuropathy, which occurred in 28% of patients (grade ≥3: 6%)
  • The incidence of serious ARs was 12.3%; the most commonly reported serious ARs were thrombocytopenia (3.8%), diarrhea (2.3%), and herpes zoster and pneumonia (1.5% each)
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Indications and Important Safety Information for VELCADE® (bortezomib)

  • INDICATIONS: VELCADE (bortezomib) is indicated for the treatment of patients with multiple myeloma and patients with mantle cell lymphoma.

  • CONTRAINDICATIONS: VELCADE is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions. VELCADE is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of VELCADE.

  • WARNINGS AND PRECAUTIONS
    VELCADE (bortezomib) is for subcutaneous or IV administration only. Because each route of administration has a different reconstituted concentration, caution should be used when calculating the volume to be administered.

    • Peripheral neuropathy, including severe cases, may occur. Patients should be monitored for symptoms and managed with dose modification or discontinuation. Patients with preexisting symptoms may experience worsening peripheral neuropathy (including ≥Grade 3). Starting with VELCADE subcutaneously may be considered for patients who either have preexisting or are at high risk for peripheral neuropathy.

    • Hypotension: Caution should be used when treating patients receiving antihypertensives, those with a history of syncope, and those who are dehydrated.

    • Cardiac toxicity, including acute development or exacerbation of congestive heart failure and new onset of decreased left ventricular ejection fraction, has occurred. Isolated cases of QT-interval prolongation have been reported. Patients with risk factors for, or existing, heart disease should be closely monitored.

    • Pulmonary toxicity: Acute respiratory distress syndrome (ARDS) and acute diffuse infiltrative pulmonary disease of unknown etiology have occurred (sometimes fatal). Pulmonary hypertension, in the absence of left heart failure or significant pulmonary disease, has been reported. In the event of new or worsening cardiopulmonary symptoms, consider interrupting VELCADE until a prompt and comprehensive diagnostic evaluation is conducted.

    • Posterior reversible encephalopathy syndrome has occurred. Consider MRI imaging for onset of visual or neurological symptoms; discontinue VELCADE if suspected.

    • Gastrointestinal toxicity, including nausea, diarrhea, constipation, and vomiting, has occurred and may require use of antiemetic and antidiarrheal medications or fluid replacement. Interrupt VELCADE (bortezomib) for severe symptoms.

    • Thrombocytopenia/Neutropenia: Manage with dose and/or schedule modifications. Complete blood counts should be monitored frequently during treatment. There have been reports of gastrointestinal and intracerebral hemorrhage. Support with transfusions and supportive care, according to published guidelines.

    • Tumor lysis syndrome: Closely monitor patients with high tumor burden and take appropriate precautions.

    • Hepatic toxicity: Monitor hepatic enzymes during treatment. Upon occurrence, interrupt therapy with VELCADE to assess reversibility.

    • Embryo-fetal risk: Women should avoid breast-feeding or becoming pregnant while on VELCADE.

    • Patients with diabetes may require close monitoring and adjustment of the antidiabetic medications.

  • DRUG INTERACTIONS: Closely monitor patients receiving VELCADE (bortezomib) in combination with strong CYP3A4 inhibitors. Avoid concomitant use of strong CYP3A4 inducers.

  • ADVERSE REACTIONS

    • Previously untreated multiple myeloma (MM): In the phase 3 study of VELCADE administered intravenously with melphalan and prednisone (MP) vs MP alone, the most commonly reported adverse reactions (ARs) were thrombocytopenia (48% vs 42%), neutropenia (47% vs 42%), peripheral neuropathy (46% vs 1%), nausea (39% vs 21%), diarrhea (35% vs 6%), neuralgia (34% vs <1%), anemia (32% vs 46%), and leukopenia (32% vs 28%).

    • Relapsed MM subcutaneous vs IV: In the phase 3 study of VELCADE (bortezomib) administered subcutaneously vs intravenously in relapsed MM, safety data were similar between the two treatment groups. The most commonly reported ARs in the subcutaneous vs IV treatment groups were peripheral neuropathy (37% vs 50%) and thrombocytopenia (30% vs 34%). The incidence of serious ARs was similar in the subcutaneous treatment group (20%) and the IV treatment group (19%). The most commonly reported serious ARs were pneumonia and pyrexia (each 2%) in the subcutaneous treatment group and pneumonia, diarrhea, and peripheral sensory neuropathy (each 3%) in the IV treatment group.

    • Previously untreated mantle cell lymphoma (MCL): In a phase 3 study of VELCADE administered intravenously with rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) vs vincristine, rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHOP), the most commonly reported ARs were neutropenia (87% vs 71%), thrombocytopenia (72% vs 17%), leukopenia (48% vs 36%), anemia (44% vs 29%), lymphopenia (28% vs 12%), peripheral neuropathy (30% vs 27%), diarrhea (25% vs 5%), nausea (23% vs 12%), and pyrexia (20% vs 10%).

    • Relapsed MM and MCL: In the integrated analysis of 1163 patients in phase 2 and 3 studies of VELCADE administered intravenously, the most commonly reported ARs were nausea (49%), diarrhea NOS (46%), fatigue (41%), peripheral neuropathy NEC (38%), and thrombocytopenia (32%). A total of 26% of patients experienced serious ARs. The most commonly reported serious ARs included diarrhea, vomiting, and pyrexia (each 3%); nausea, dehydration, and thrombocytopenia (each 2%); and pneumonia, dyspnea, peripheral neuropathies NEC, and herpes zoster (each 1%).

  • Please see full Prescribing Information available at www.VELCADE.com

View full U.S. Prescribing Information


VISTA TRIAL: a randomized, open-label, international phase 3 trial (N=682) evaluating the efficacy and safety of VELCADE (bortezomib) administered intravenously in combination with MP vs MP in previously untreated multiple myeloma. After progressive disease was established, all patients were eligible to receive subsequent therapies. The primary endpoint was TTP. Secondary endpoints were CR, ORR, PFS, and OS. At a prespecified interim analysis (median follow-up 16.3 months), VELCADE+MP resulted in significantly superior results for TTP (median 20.7 months with VELCADE+MP vs 15.0 months with MP [p=0.000002]), PFS, OS, and ORR. Further enrollment was halted, and patients receiving MP were offered VELCADE in addition. Updated analyses were performed.

RETRIEVE TRIAL: a single-arm, open-label study that evaluated the efficacy and safety of retreatment with (IV) VELCADE (N=130). Patients with multiple myeloma who had previously achieved ≥PR on a VELCADE-containing regimen (median of 2 prior lines of therapy [range: 1-7]) and progressed ≥6 months after completing that regimen were retreated with IV VELCADE (±dexamethasone). Patients received VELCADE on days 1, 4, 8, and 11 q 3 weeks for 24 weeks. The primary endpoint was best confirmed response to treatment as assessed by European Group for Blood and Marrow Transplantation criteria. Secondary endpoints were DOR and safety.

References: 1. Mateos M-V, Richardson PG, Schlag R, et al. Bortezomib plus melphalan and prednisone compared with melphalan and prednisone in previously untreated multiple myeloma: updated follow-up and impact of subsequent therapy in the phase III VISTA trial. J Clin Oncol. 2010;28(13):2259-2266. 2. Data on file 48, Millennium Pharmaceuticals, Inc.

Important Safety Information for VELCADE® (bortezomib)