Velcade (Bortezomib) Consolidation After Transplant

NCT01539083 | Completed Phase 3 Results DMC

• 2 other identifiers: CR01875126866138-MMY-2073
• Study Type: interventional
• Target: 256
• Locations: 3 countries
• Sites: 23

Brief 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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Bortezomib; VELCADE; Consolidation therapy; Subcutaneous; Thalidomide; Prednisolone; Autologous stem cell transplant (ASCT); VELCADE, cyclophosphamide, dexamethasone (VCD) induction therapy

Outcome Measures

Primary Outcomes (1)

• Consolidation Phase: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) at 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.

  Month 12

Secondary Outcomes (7)

• Consolidation Phase: Percentage of Participants With Complete Response (CR) at Months 3, 6, 9 and 12

  Months 3, 6, 9 and 12

• Consolidation Phase: Percentage of Participants With Stringent Complete Response (sCR) at Months 3, 6, 9 and 12

  Months 3, 6, 9 and 12

• Progression Free Survival (PFS)

  Baseline until progressive disease (up to 5 years)

• Disease-free Survival (DFS)

  Up to 5 years

• Overall Survival (OS)

  Up to 5 years

Study Arms (3)

Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction]

EXPERIMENTAL

Bortezomib (Velcade) 1.3 milligram per square meter (mg/m\^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m\^2 orally on Days 1, 8, and 15; and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.

Drug: Bortezomib; Drug: Cyclophosphamide; Drug: Dexamethasone

Thalidomide + Prednisolone [TP Consolidation]

EXPERIMENTAL

Thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.

Drug: Thalidomide; Drug: Prednisolone

Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]

EXPERIMENTAL

Bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.

Drug: Thalidomide; Drug: Bortezomib; Drug: Prednisolone

Interventions

Thalidomide DRUG

Thalidomide 100 mg tablet, orally.

Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]; Thalidomide + Prednisolone [TP Consolidation]

Bortezomib DRUG

Bortezomib 1.3 milligram per square meter (mg/m\^2) solution for injection subcutaneously (SC).

Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction]; Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]

Cyclophosphamide DRUG

Cyclophosphamide 300 mg/m\^2 orally.

Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction]

Dexamethasone DRUG

Dexamethasone 20 mg orally.

Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction]

Prednisolone DRUG

Prednisolone 50 mg orally.

Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]; Thalidomide + Prednisolone [TP Consolidation]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen Scientific Affairs, LLC: lead

Study Sites (23)

Unknown Facility

Adelaide, Australia

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Camperdown, Australia

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Geelong, Australia

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Greenslopes, Australia

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Heidelberg, Australia

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Herston, Australia

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Malvern, Australia

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Melbourne, Australia

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Nedlands, Australia

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Newcastle, Australia

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Prahran, Australia

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Sydney, Australia

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Westmead, Australia

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Woodville South, Australia

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Woolloongabba, Australia

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Beijing, China

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Guangzhou, China

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Shanghai, China

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Tianjin, China

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Busan, South Korea

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Daegu, South Korea

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Jeollanam-do, South Korea

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Ulsan, South Korea

Location

Related Publications (1)

• Horvath N, Spencer A, Kenealy M, Joshua D, Campbell PJ, Lee JJ, Hou J, Qiu L, Kalff A, Khong T, Londhe A, Siggins S, van Kooten Losio M, Eisbacher M, Prince HM. 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. Leuk Lymphoma. 2019 Sep;60(9):2122-2133. doi: 10.1080/10428194.2019.1579322. Epub 2019 Feb 19.

  PMID: 30777794 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Thalidomide; Bortezomib; Cyclophosphamide; Dexamethasone; Prednisolone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Clinical Leader
• Organization: Janssen R&D

ClinicalTrialDisclosure@its.jnj.com

Study Officials

• Janssen Asia-Pacific Medical Affairs Clinical Trial

  Janssen Asia-Pacific Medical Affairs

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2011
• First Posted: February 27, 2012
• Study Start: January 13, 2012
• Primary Completion: December 30, 2015
• Study Completion: January 9, 2018
• Last Updated: February 4, 2025
• Results First Posted: February 9, 2017

Record last verified: 2025-01

Locations

KR (4); CN (4); AU (15)