Combination Bortezomib-containing Regimens in Newly Diagnosed Patients With t (4; 14) Positive Multiple Myeloma
This study is ongoing, but not recruiting participants.
Sponsor:
University Health Network, Toronto
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: March 21, 2013
Last verified: March 2013
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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 ]
| Estimated Enrollment: | 45 |
| 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
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: | March 21, 2013 |
| 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 May 21, 2013