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Velcade (Bortezomib) Consolidation After Transplant (VCAT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT01539083
First received: November 23, 2011
Last updated: December 16, 2016
Last verified: December 2016
  Purpose
The purpose of this study is to determine if bortezomib when added to consolidation treatment with thalidomide and prednisolone leads to an improved response in patients with multiple myeloma who have undergone autologous stem cell transplant and initial treatment with bortezomib, cyclophosphamide, and dexamethasone.

Condition Intervention Phase
Multiple Myeloma
Drug: Thalidomide
Drug: Bortezomib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomised Trial of Bortezomib Consolidation (With Thalidomide and Prednisolone) Vs Thalidomide and Prednisolone Alone in Previously Untreated Subjects With Multiple Myeloma After Receiving Bortezomib, Cyclophosphamide, Dexamethasone (VCD) Induction and Autologous Stem Cell Transplant

Resource links provided by NLM:


Further study details as provided by Janssen Scientific Affairs, LLC:

Primary Outcome Measures:
  • Consolidation Phase: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) at Month 12 [ Time Frame: Month 12 ]
    CR as per IMWG criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (<) 5 percent plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90 percent or greater reduction in serum M-protein plus urine M-protein level <100 milligram (mg) per 24 hours.


Secondary Outcome Measures:
  • Consolidation Phase: Pecentage of Participants With Complete Response (CR) at Months 3, 6, 9 and 12 [ Time Frame: Months 3, 6, 9 and 12 ]
    CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow.

  • Consolidation Phase: Percentage of Participants With Stringent Complete Response (sCR) at Months 3, 6, 9 and 12 [ Time Frame: Months 3, 6, 9 and 12 ]
    sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow. CR is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow.

  • Consolidation Phase: Progression Free Survival (PFS) [ Time Frame: Baseline until progressive disease (up to 3 years) ]
    PFS, calculated as the time between randomization to disease progression or death (regardless of cause), whichever occurred first. Progressive disease as per IMWG criteria: increase of >= 25 percent from lowest response level in Serum M-component and/or (the absolute increase must be >=0.5 gram per deciliter [g/dL]) Urine M-component and/or (the absolute increase must be >=200 mg/24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be >10 mg/dL. Bone marrow plasma cell percentage: the absolute percent must be >=10 percent. 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 hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 millimole per liter (mmol/L) that can be attributed solely to the plasma cell proliferative disorder.

  • Consolidation Phase: Disease-free Survival (DFS) [ Time Frame: Up to 3 years ]
    DFS, defined as the duration from the start of CR to the time of relapse from CR. DFS applied only to participants in CR. CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow. Relapse from CR: reappearance of serum or urine M-protein by immunofixation or electrophoresis; development of >= 5 percent plasma cells in the bone marrow; appearance of any other sign of progression (ie, new plasmacytoma, lytic bone lesion, or hypercalcaemia).

  • Consolidation Phase: Overall Survival (OS) [ Time Frame: Up to 3 years ]
    OS was defined as the time between randomization and death. Death of a participant regardless of the cause was considered as an event.

  • Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase [ Time Frame: Month 12 ]
    The assessment of quality of life-6D (AQoL-6D) is a multi-attribute health-related quality of life instrument (QoL). It comprises dimension scores for independent living, relationships, mental health, coping, pain, senses, and utility score for AQol-6D. Each scale ranges between 1 (best QoL) and -0.04 (worst possible QoL).

  • Consolidation Phase: Change From Baseline in FACT/GOG-NTX Total Score at the End of the Consolidation Phase [ Time Frame: Month 12 ]
    Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) consists of 10 items and evaluates symptoms and concerns associated specifically with chemotherapy-induced neuropathy. 1 FACT/GOG-NTX total score has a range of 0 to 108 with a higher score indicating better quality of life.


Enrollment: 256
Study Start Date: January 2012
Estimated Study Completion Date: January 2018
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Thalidomide
Thalidomide consolidation and prednisolone maintenance therapy
Drug: Thalidomide
Thalidomide: Type=1, unit=mg, number=100, form=tablet, route=oral use. Oral thalidomide consolidation will be administered for a maximum of 12 months or until disease progression along with Prednisolone: Type=1, unit =mg, number=50, form=tablet, route=oral use. Prednisolone maintenance therapy will be administered on alternate days continued indefinitely or until disease progression.
Experimental: Bortezomib + Thalidomide
Bortezomib + Thalidomide consolidation and prednisolone maintenance therapy.
Drug: Bortezomib
Type=1, unit=mg/ml, number=2.5, form= Solution for injection, route=Subcutaneous use. Bortezomib will be administered as a single subcutaneous injection at a concentration of 1.3 mg/m2 every 2 weeks for 32 weeks (16 doses) in addition to 100 mg daily oral thalidomide consolidation for a maximum of 12 months or until disease progression and 50 mg oral alternate-day prednisolone maintenance continued indefinitely or until disease progression.
Drug: Thalidomide
Type=1, unit=mg, number=100, form=tablet, route=oral use. 100 mg daily oral thalidomide consolidation (administered in addition to bortezomib) will be administered for a maximum of 12 months or until disease progression and 50 mg oral alternate-day prednisolone maintenance continued indefinitely or until disease progression.

Detailed Description:

This is an open-label (patients will know the identity of study treatments), randomized (patients will be assigned by chance to different treatments) study of bortezomib administered as consolidation therapy (therapy given once a remission is achieved) with thalidomide and prednisolone versus thalidomide and prednisolone alone in previously untreated patients with multiple myeloma. Multiple myeloma is a cancer of your plasma cells, a type of white blood cell present in your bone marrow. Patients in this study will receive initial therapy with bortezomib, cyclophosphamide, and dexamethasone (referred to as VCD induction therapy) and will undergo autologous stem cell transplant (ASCT) (a procedure where patients receive an infusion of immature blood cells [stem cells] from their own body to replenish the body's supply of healthy blood-forming cells) before randomization to one of two treatments: Treatment A (thalidomide for up to 12 months or until disease progression and prednisolone on alternate days continued indefinitely or until disease progression) or Treatment B (bortezomib for 32 weeks in addition to thalidomide up to 12 months or until disease progression and prednisolone on alternate days, continued indefinitely or until disease progression.

Throughout the study, the patient's response to therapy will be assessed according to protocol-defined efficacy evaluations and by implementing defined disease response criteria (International Myeloma Working Group [IMWG] criteria). Safety will be evaluated throughout the study. Follow up for progression-free survival (PFS) and overall survival (OS) will be conducted from time of randomization to 3 years post-randomization.

Two interim analyses are planned. The final analysis will be conducted after all patients have completed 12-month consolidation treatment phase or discontinued. The primary endpoint of number and percent of patients with complete response and very good partial response defined by IMWG criteria for multiple myeloma will be examined in the interim and final analyses after approximately 12 months of consolidation therapy. At the completion of the study, updated analyses of PFS and OS will be performed.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Previously diagnosed with multiple myeloma based on international myeloma working group (IMWG) criteria.and meet all of the following; Serum M-protein greater than or equal to (>=) 1 gram per deciliter (g/dL) (>=10 gram per liter); Urine M-protein >=200 milligram (mg) per 24 hour and Serum Free Light chain (FLC) assay: Involved FLC Level >=10 mg/dL (>=100 mg/L) provided serum FLC ratio is normal
  • Meet the pretreatment laboratory criteria as specified in the study protocol at and within 21 days before baseline (Day 1 of Cycle 1, before bortezomib administration for induction).
  • Have ECOG status 0-2.
  • Men and women must practice an appropriate method of birth control as specified in the study protocol from signing of the informed consent form though to the 12-month visit/early termination visit.

Exclusion criteria:

  • Has previously received treatment for multiple myeloma (including prior therapy with radiation or pulsed dexamethasone) as specified in the study protocol.
  • Has a history of any other malignancy within 5 years before enrolment as specified in the study protocol.
  • Has had major surgery as specified in the study protocol within 30 days before enrolment.
  • Had a myocardial infarction within 6 months of enrolment or has New York Heart Association (NYHA) Class III or IV heart failure (or other clinically significant cardiac medical history as specified in the study protocol).
  • Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539083

Locations
Australia
Adelaide, Australia
Camperdown, Australia
Geelong, Australia
Greenslopes, Australia
Heidelberg, Australia
Herston, Australia
Malvern, Australia
Melbourne, Australia
Nedlands, Australia
Newcastle, Australia
Prahran, Australia
Sydney, Australia
Westmead, Australia
Woodville South, Australia
Woolloongabba, Australia
China
Beijing, China
Shanghai, China
Tianjin, China
Korea, Republic of
Busan, Korea, Republic of
Daegu, Korea, Republic of
Hwasun Gun, Korea, Republic of
Ulsan, Korea, Republic of
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Investigators
Study Director: Janssen Asia-Pacific Medical Affairs Clinical Trial Janssen Asia-Pacific Medical Affairs
  More Information

Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT01539083     History of Changes
Other Study ID Numbers: CR018751
26866138-MMY-2073 ( Other Identifier: Janssen Asia-Pacific Medical Affairs )
Study First Received: November 23, 2011
Results First Received: December 16, 2016
Last Updated: December 16, 2016

Keywords provided by Janssen Scientific Affairs, LLC:
Multiple Myeloma
Bortezomib
VELCADE
Consolidation therapy
Subcutaneous
Thalidomide
Prednisolone
Autologous stem cell transplant (ASCT)
VELCADE, cyclophosphamide, dexamethasone (VCD) induction therapy

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Thalidomide
Dexamethasone
Prednisolone
Methylprednisolone Hemisuccinate
Bortezomib
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on March 28, 2017