Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KRdD followed by auto-HCT · 1 trial · 1 indication
The primary endpoint of MRD(-) rate, or percentage of patients with MRD(-) remissions, will be estimated along with two-sided 95% confidence interval using Clopper-Pearson exact method. Simon's optimal two-stage design will be utilized in determining the rate of MRD(-) cases. MRD assessment will be done with ClonoSEQ to identify myeloma-specific sequences.
| Arm | Type | Description |
|---|---|---|
| KRdD followed by auto-HCT | EXPERIMENTAL | Cycle 1-Dexamethasone 40mg orally days 1/8/15/22; Lenalidomide 25mg orally days 1-21; Carfilzomib 20mg/m2 days 8/9 then 36mg/m2 venous days 15/16; Daratumumab 16mg/kg venous days 1/8/15/22 (KRd-Dara). Cycle 2 the same except Carfilzomib 36mg/m2 venous days 1/2/8/9/15/16. Cycles 3,4 the same but no Daratumumab Days 8 and 22. Dosage adjusted for last tolerated dose (LTD). Following induction therapy, auto-HCT is done (consolidation 1), then up to two 4-cycle blocks of KRd-Dara consolidation (consolidations 2 and 3). Minimum residual disease (MRD) checked after each phase. Patients with confirmed MRD(-) at or after consolidation 1 will not undergo maintenance and will be actively monitored for resurgence of MRD or clinical relapse. After consolidation if MRD+ patients will undergo standard of care lenalidomide maintenance. |
| KRdD only | EXPERIMENTAL | Cycle 1-Dexamethasone 40mg orally days 1/8/15/22; Lenalidomide 25mg orally days 1-21; Carfilzomib 20mg/m2 days 8/9 then @ 36mg/m2 venous days 15/16; Daratumumab 16mg/kg venous days 1/8/15/22. Cycle 2 the same except Carfilzomib 36mg/m2 venous days 1/2/8/9/15/16. Cycles 3,4 the same but no Daratumumab Day 22. Dosage adjusted for last tolerated dose (LTD). Following induction therapy, Following induction therapy, patients will receive up to three 4-cycle blocks of KRd-Dara consolidation (consolidations 1, 2 and 3). Minimum residual disease (MRD) checked after each phase. Patients with confirmed MRD(-) at or after consolidation 1 will not undergo maintenance and will be actively monitored for resurgence of MRD or clinical relapse. After consolidation if MRD+ patients will undergo standard of care lenalidomide maintenance. |
| Name | Type | Description |
|---|---|---|
| KRdD followed by auto-HCT | DRUG | Dosages of each drug will vary depending on therapy type and cycle number. KRdD therapy will be followed by autologous hematopoietic cell transplantation and KRdD consolidation. |
| KRdD only | DRUG | Dosages of each drug will vary depending on therapy type and cycle number. KRdD therapy will not be followed by autologous hematopoietic cell transplantation but will proceed with KRdD consolidation. |
Inclusion Criteria: * Age \>18 years with no upper age limit * Diagnosis of newly diagnosed multiple myeloma with indication for initiation of therapy. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * No prior MM-directed therapy except for dexamethasone (up to 160 mg) and/or bo...
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KRdD followed by auto-HCT is an investigational combination regimen being studied for the treatment of multiple myeloma. It is a small molecule therapy developed by Amgen Inc. The regimen is being evaluated in a Phase 2 clinical trial to assess its effectiveness in achieving deep remission in patients with this blood cancer.
KRdD followed by auto-HCT is a combination regimen that includes carfilzomib, lenalidomide, dexamethasone, and daratumumab. Carfilzomib is a proteasome inhibitor, lenalidomide is an immunomodulatory drug, dexamethasone is a corticosteroid, and daratumumab is a monoclonal antibody targeting CD38. The regimen is followed by autologous stem cell transplantation.
KRdD followed by auto-HCT is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. Amgen is conducting clinical research on this combination regimen for the treatment of multiple myeloma.
KRdD followed by auto-HCT is in Phase 2 clinical development. It is an investigational regimen, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to evaluate its safety and efficacy in patients with multiple myeloma.
KRdD followed by auto-HCT is being studied in a Phase 2 clinical trial with the identifier NCT03224507, titled 'Monoclonal Antibody-Based Sequential Therapy for Deep Remission in Multiple Myeloma.' This completed trial enrolled 123 participants in the United States and included patients aged 18 years and older.