Multiple Myeloma Clinical Trial
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
Verified date | August 2020 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | September 15, 2015 |
Est. primary completion date | September 15, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Cross Cancer Institute 11560 University Ave | Edmonton | Alberta |
Canada | Queen Elizabeth II Health Sciences Centre. | Halifax | Nova Scotia |
Canada | London Regional Cancer Program 790 Commissioners Road East | London | Ontario |
Canada | The Ottawa Hospital | Ottawa | Ontario |
Canada | Saskatoon Cancer Centre 20 Campus Drive | Saskatoon | Saskatchewan |
Canada | Princess Margaret Hospital | Toronto | Ontario |
Canada | CancerCare Manitoba 675 McDermot Ave. | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Ortho Biotech, Inc., Princess Margaret Hospital, Canada |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the time to progression (TTP) with this treatment regimen | Measured from the date of enrollment to the date of disease progression. Otherwise, censored at the time of last disease assessment. Responses were assessed using the International Myeloma Working Group criteria, involving a modified version of the European Group for Blood and Marrow Transplantation (EBMT) criteria, where the category of stringent complete response (sCR) was included for patients with normalization of the free light chain ratio.10,11 Bone marrow aspirate and biopsy were obtained routinely after induction therapy to confirm CR or sCR. Serum free light chain assay and serum and/or urine electrophoresis were performed monthly; immunofixation was performed when confirmation of very good partial response (VGPR), CR, or sCR was necessary. | Patients were followed monthly until disease progression and subsequently every six months for up to five years to assess OS. | |
Secondary | To determine the objective response rate/duration following DBd induction and Cybor P post induction therapy | Objective response after completing induction therapy and until disease progression. | Patients were followed monthly until disease progression | |
Secondary | To determine PFS | PFS was measured from the date of enrollment to the date of disease progression or death from any cause, otherwise censored at the time of last disease assessment. | 5 years | |
Secondary | To determine overall survival | Patients were followed monthly until disease progression and subsequently every six months for up to five years to assess OS. | 5 years | |
Secondary | To determine the safety profile of this regimen | Safety analyses focused on hematological and non-hematological adverse events of all grades. Toxicity was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 3.0) | 5 years |
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