Phase 3
Completed N=256
Velcade (Bortezomib) Consolidation After Transplant
Source: ClinicalTrials.gov NCT01539083 ↗Enrolled (actual)
256
Serious AEs
30.3%
Results posted
Feb 2017
Primary outcomePrimary: Consolidation Phase: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) at Month 12 — 81.3; 92.9 percentage of participants
◆ Published Evidence
Emerging
17citations · ~2 / year
Phase 3 study of subcutaneous bortezomib, thalidomide, and prednisolone consolidation after subcutaneous bortezomib-based induction and autologous stem cell transplantation in patients with previously untreated multiple myeloma: the VCAT study.
Summary
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.
Linked Publications
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Phase 3 study of subcutaneous bortezomib, thalidomide, and prednisolone consolidation after subcutaneous bortezomib-based induction and autologous stem cell transplantation in patients with previously untreated multiple myeloma: the VCAT study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Consolidation Phase: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) at Month 12 |
81.3; 92.9 | — |
| SECONDARY Consolidation Phase: Percentage of Participants With Complete Response (CR) at Months 3, 6, 9 and 12 |
36.5; 36.7; 44.8; 44.9; 49.0; 52.0 | — |
| SECONDARY Consolidation Phase: Percentage of Participants With Stringent Complete Response (sCR) at Months 3, 6, 9 and 12 |
20.8; 23.5; 27.1; 28.6; 26.0; 30.6 | — |
| SECONDARY Progression Free Survival (PFS) |
22.05; 22.51 | — |
| SECONDARY Disease-free Survival (DFS) |
18.53; 13.37 | — |
| SECONDARY Overall Survival (OS) |
NA; NA | — |
| SECONDARY Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase |
0.15; 0.14; 0.06; 0.05; 0.18; 0.18 | — |
| SECONDARY Consolidation Phase: Change From Baseline in FACT/GOG-NTX Total Score at the End of the Consolidation Phase |
2.9; 1.0 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01539083) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.