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Association details:
Biomarker:No biomarker
Cancer:Multiple Myeloma
Regimen:VTD (bortezomib + dexamethasone injection + thalidomide)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: A1 - Approval
New
Excerpt:
Velcade in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high dose chemotherapy with haematopoietic stem cell transplantation.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Title:

Multiple myeloma: EHA-ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Published date:
02/03/2021
Excerpt:
Recommendations: The four-drug combination DaraVTD is more efficacious than VTD [I, A] and is the new standard of care. If this is not available, VTD [I, A] or VCD [II, B] may be used.
DOI:
10.1016/j.annonc.2020.11.014
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
Multiple Myeloma: Useful In Certain Circumstances…Bortezomib/thalidomide/dexamethasone…
Evidence Level:
Sensitive: B - Late Trials
Title:

Bortezomib, thalidomide, and dexamethasone followed by double autologous haematopoietic stem-cell transplantation for newly diagnosed multiple myeloma (GIMEMA-MMY-3006): long-term follow-up analysis of a randomised phase 3, open-label study

Published date:
11/23/2020
Excerpt:
In this randomised, open-label, phase 3 study, patients aged 18–65 years with previously untreated symptomatic multiple myeloma...VTD was an independent predictor of improved progression-free survival (HR 0·60 [95% CI 0·48–0·76]; p<0·0001) and overall survival (HR 0·68 [0·50–0·91]; p=0·010).
DOI:
10.1016/S2352-3026(20)30323-9
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Efficacy of Daratumumab Based Regimens Compared to Standard of Care for Transplant Eligible Multiple Myeloma in Phase III Clinical Trials: A Meta-Analysis

Published date:
11/04/2020
Excerpt:
...efficacy of Dara + bortezomib (V) + thalidomide (T) + dexamethasone (d) vs VTd in NDMM pts (n=1085) in CASSIOPEIA phase III trial...reported efficacy of Dara addition to lenalidomide (R), and Vd vs RVd in GRIFFIN study in transplant eligible NDMM patients (n= 207). A pooled analysis of these trials showed ORR (OR: 1.73, 95% CI 1.16-2.59; p < 0.008, I2 = 80%). Addition of Dara to the standard care regimen (VRd, VTd) for transplant eligible NDMM achieved the surrogate endpoints with improved efficacy...
DOI:
10.1182/blood-2020-141761
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

A Systematic Review of Daratumumab Based Four Drug Regimen for Newly Diagnosed Multiple Myeloma in Phase III Clinical Trials

Published date:
11/04/2020
Excerpt:
...efficacy of Dara + bortezomib (V) + thalidomide (T) + dexamethasone (d) vs VTd in newly diagnosed MM (NDMM) pts (n=1085) in CASSIOPEIA phase III trial. Addition of Dara to VTd group showed marked improvement in progression-free survival (PFS): 93% vs 85% at 18 months (hazard ratio (HR) 0.42 [0.34-0.51]; p<0.0001), and overall response rate (ORR) of 92.6% in Dara + VTd group as compared to 89.9% in VTd group (CI: 95%, P<0.0001)...addition of Dara to lenolidamide (R), and Vd in GRIFFIN study. Addition of Dara to VRd resulted in improved PFS: 95.8% ((95% CI, 89.2- 98.4) vs 89.8% ((95% CI, 77.1-95.7) at 24 months), and ORR of 99% (Odd's ratio (OR) 8.75 with 95% CI: 1.08-71.01; p=0.0160) in Dara + VRd group vs VRd group (91.8%)...eported the role of Dara + V + melphalan (M) + prednisone (P) vs VMP...Addition of Dara to VMP group showed marked improvement in PFS: 63% vs 36 at 24 months (HR: 0.47, 95% CI 0.33-0.67, p<0.0001), and ORR: 90.9% vs 73.9%, respectively. NDMM treatment with Dara in four-drug regimens (VTd, VMP, VRd) has shown promising outcomes with improved efficacy...
DOI:
10.1182/blood-2020-138466
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

A Systematic Review of Phase III Clinical Trials of Daratumumab Addition to Standard Care Regimen for Newly Diagnosed Multiple Myeloma

Published date:
11/04/2020
Excerpt:
...efficacy of Dara + bortezomib (V) + thalidomide (T) + dexamethasone (d) in NDMM pts (n=1085) in CASSIOPEIA phase III trial. Addition of Dara to VTd group showed marked improvent in progression free survival (PFS): 93% vs 85% at 18 months (hazard ratio (HR) 0.42 [0.34-0.51]; p<0.0001), and overall response rate (ORR) of 92.6% (CI: 95%, P <0.0001) in Dara + VTd group as compared to VTd group (89.9%)...Dara + lenolidamide (R) and dexamethasone (d) in NDMM pts (n=737) in MAIA phase III trial...Dara + V + melphalan (M) + prednisone (P) vs VMP in NDMM pts (n=706) in a phase III trial (Alcyone). Addition of Dara to Rd, and VMP group showed marked improvent in PFS: 68% vs 46% at 36 months [confidence interval [CI], 0.44-0.71; P<0.0001], and 63% vs 36 at 24 months (HR: 0.47, 95% CI 0.33-0.67, p<0.0001), and ORR: 93% vs 82% (P<0.0001), and 90.9% vs 73.9%, respectively. NDMM treatment with Dara plus standard care therapy (VTd, VMP, Rd) has shown promising outcomes...
DOI:
10.1182/blood-2020-134895