At a glance
ClinicalIndex Comparison Record- ✓Newly diagnosed active multiple myeloma requiring treatment, or smoldering myeloma with evidence of progressive disease requiring chemotherapy
- ✓Quantifiable M-component (IgG, IgA, IgD, or IgE) and/or urinary light chain, or non-secretory with >20% plasmacytosis or multiple (>3) focal plasmacytomas on MRI or diffuse hyperintense signal on STIR
- ✓Age ≤75 years at initial registration
- ✓No more than one prior chemotherapy cycle for this disease
- ✕Platelet count <30×10⁹/L unless myeloma-related
- ✕ANC <1.0×10⁹/L unless myeloma-related
- ✕Grade ≥2 peripheral neuropathy
- ✕Hypersensitivity to bortezomib, boron, or mannitol
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Study Incorporating Bone Marrow Microenvironment (ME) Co-Targeting Bortezomib Into Tandem Melphalan-Based Autotransplants With DT PACE for Induction/Consolidation and Thalidomide + Dexamethasone for Maintenance
In Brief
A Phase 2 clinical trial evaluating Velcade and Thalidomide for Multiple Myeloma. Completed, enrolled 303 participants across 1 site.
Detailed Summary
There have been two previous Total Therapy studies for multiple myeloma (MM) at the Myeloma Institute for Research and Therapy (MIRT): Total Therapy I (from 1989 through 1994) and Total Therapy II (from 1996 to 2004). Results have shown that patients treated on these studies had better outcomes (meaning patients have lived longer and had better responses to treatment) when compared to patients treated with standard chemotherapy. With this new study, Total Therapy III, researchers will take what they have learned from the first two studies and add new treatment strategies to try to improve the outcomes even more, especially for patients with chromosome abnormalities.
Study Details
Timeline
Interventions
Two cycles of induction on days 1,4,8,11 at 1.0mg/m\^2. Two cycles of consolidation on days 1,4,8,11 at 1.0mg/m\^2. Maintenance year one 1.0mg/m\^2 1,4,8,11 q 28 days.
Two cycles of VDTPACE 200mg thal days 4-7(cycle 1)and days 1-4 cycle 2 interim Thal 50mg qd between VTDPACE cycles and between cycle 2 and transplant. Thal 100mg between transplants d/c 7 days prior to each transplant. Consolidation therapy cycles 3 and 4 VDTPACE 200mg days 1-4 both cycles. Interim maintenance to maintenance 100mg qd. Maintenance year 1 thal 100mg qd. Maintenance years 2 and 3 Thal 100mg qd.