Combination Bortezomib-containing Regimens in Newly Diagnosed Patients With t (4; 14) Positive Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Princess Margaret Hospital, Canada
Ortho Biotech, Inc.
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00570180
First received: December 6, 2007
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

Given the disappointing results with routine ASCT in t(4;14) patients, we propose this open label phase II study of bortezomib along with dexamethasone and pegylated liposomal doxorubicin (Doxil/Caelyx), referred to as the DBd regimen, for 4 cycles, followed by post-induction therapy with cyclophosphamide + bortezomib + prednisone (referred to as the CyBorP regimen) for 8 cycles. Since patients with t(4;14) remain at high risk for relapse, maintenance therapy with dexamethasone weekly will be given until disease progression.


Condition Intervention Phase
Multiple Myeloma
Drug: Bortezomib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Phase II Study of the Efficacy of Combination Bortezomib-containing Regimens in the Treatment of Newly Diagnosed Patients With t (4; 14) Positive Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • To determine the time to progression (TTP) with this treatment regimen [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the objective response rate/duration following DBd induction and Cybor P post induction therapy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To determine PFS [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To determine overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To determine the safety profile of this regimen [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: November 2007
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm
Please see intervention description
Drug: Bortezomib
21 day-cycle Induction therapy:bortezomib 1.3 mg/m2 (I.V. Days 1, 4, 8, and 11), then 10-day rest period. DOXIL 30 mg/m2 given after bortezomib (I.V. infusion Day 4 of each cycle). Dexamethasone 40 mg PO on days 1-4,8-11 and 15-18 during the first cycle. Subsequent 3 cycles, dexamethasone 40 mg PO given on days 1-4 and 11-14. Patients who don't progress may undergo elective stem cell mobilization, stem cell collection and cryopreservation. Patients will then receive post-induction therapy 1.5 mg/m2 bortezomib days 1, 8, and 15 I.V. + cyclophosphamide 300 mg/m2 PO weekly + prednisone 100 mg PO on alternate days for 8 monthly 28 day cycles.Maintenance therapy with weekly 40 mg dexamethasone (days 1, 8, 15 and 22) every month until disease progression occurs.
Other Name: Velcade

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients previously diagnosed with MM based on criteria from the International Myeloma Working Group (IMWG)
  • Patients who have 'measurable' disease
  • Age 18 years at the time of signing Informed Consent
  • A patient may have received up to 4 months of other anti myeloma therapy, as part of the induction therapy, prior enrollment and still be considered eligible to participate in the study, as long as the patient's multiple myeloma has not progressed on the current regimen and the other eligibility criteria are met.
  • Patient is t(4;14) positive on screening assay.

Exclusion Criteria:

  • Concomitant therapy medications that include corticosteroids (> 10 mg per day of prednisone or equivalent) or other therapy that is or may be active against myeloma prior to day 1 (with the exception of radiation therapy or induction therapy as described under the above inclusion criteria section
  • Peripheral neuropathy of Grade 2 or greater.
  • Patients with evidence of mucosal or internal bleeding and/or refractoriness to platelet transfusions (i.e., unable to maintain a platelet count 50 x 109 /L).
  • Patients with an absolute neutrophil count (ANC) < 1.0 x 109/L. Treatment to raise the ANC, such as granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) is not allowed within 14 days of study entry.
  • Patients with hemoglobin < 80 g/L despite transfusion.
  • Pregnant or lactating women
  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: NCT00570180

Locations
Canada, Alberta
Cross Cancer Institute 11560 University Ave
Edmonton, Alberta, Canada, T6G-1Z2
Canada, Manitoba
CancerCare Manitoba 675 McDermot Ave.
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre.
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
London Regional Cancer Program 790 Commissioners Road East
London, Ontario, Canada, N6A 4L6
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Saskatchewan
Saskatoon Cancer Centre 20 Campus Drive
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Ortho Biotech, Inc.
Investigators
Principal Investigator: Donna E. Reece, MD University Health Network, Princess Margaret Hospital
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00570180     History of Changes
Other Study ID Numbers: 26866138-MMY-2016, t4;14 trial PMH
Study First Received: December 6, 2007
Last Updated: May 23, 2014
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
newly diagnosed

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
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014