Clinical studies ongoing in patients with high-risk features
| Registration number . | Study design . | Population . |
|---|---|---|
| ND high-risk MM | ||
| NCT03104842 | Isatuximab-KRd as induction, consolidation, and maintenance | Transplant eligible or ineligible del(17p) in ≥10% of purified cells and/or t(4;14) and/or >3 copies +1q21 ISS II or III |
| NCT03756896 | Carfilzomib, pomalidomide, and dexamethasone as maintenance after HDM-ASCT | Transplant eligible achieving at least partial response Presence of del(17p), t(4;14), t(14;16), t(14;20) PCL at diagnosis |
| NCT04025450 | Chidamide (HDAC inhibitor)–lenalidomide, bortezomib, and dexamethasone as induction | Transplant eligible and ineligible Presence of del(17p), t(4;14), t(14;16), t(14;20) R-ISS III IgD/IgE Extramedullary plasmacytomas Peripheral plasma cells by flow cytometry ≥0.165% |
| NCT02128230 | Induction with melphalan 20–KTD-PACE followed by melphalan 80–KTd-PACE plus ASCT and KTD-PACE consolidation and KRd maintenance (1 year) and Kd (1 year) | Transplant eligible GEP70 risk score of ≥0.66 |
| NCT03549442 | BCMA CAR-T + huCART19 in different schedules | ISS III or R-ISS III or Metaphase karyotype with >3 abnormalities except hyperdiploidy Failure to achieve partial response or better to initial therapy based on PI and IMiD |
| NCT04196491 | BCMA CAR-T bb2121 (ide-cel) (150-800 × 106) followed by lenalidomide as maintenance | R-ISS III |
| NCT04436029 | Autologous CD8+ T cells expressing an anti-BCMA chimeric antigen receptor | High-risk patients who completed pretransplant induction antimyeloma treatment |
| NCT04133636 | BCMA CAR-T JNJ-68284528 (cilta-cel) followed by lenalidomide maintenance | Less than complete response after first-line treatment and transplant followed or not by consolidation |
| NCT04133636 | BCMA CAR-T JNJ-68284528 (cilta-cel) followed by lenalidomide and daratumumab maintenance | Noneligible for transplant patients with ISS III |
| Relapsed-refractory high-risk MM | ||
| NCT03601078 | BCMA CAR-T bb2121 (150-450 × 106) | R-ISS III and PD <18 months after the first-line treatment including induction, transplant, and lenalidomide maintenance PD <18 months since date of start initial therapy, which must contain PI, IMiD, and dexamethasone Less thanVGPR after induction, including PI, IMiD, and dexamethasone and transplant (between 70 and 110 days after transplant) |
| NCT04133636 | BCMA CAR-T JNJ-68284528 (cilta-cel) | One prior line including PI, IMiD, and PD within the first 12 months after transplant or the first-line treatment for nontransplant eligible |
| NCT03104270 | Elotuzumab in combination with pomalidomide, carfilzomib, and dexamethasone | More than 2 prior lines, including PI and IMiD and del(17p), t(14;16), t(14:20) PCL Extramedullary disease Doubling in levels of MM markers in the past 3 months Refractoriness to their most recent lenalidomide-containing regimen and PI-based regimen Renal failure with CrCl between 15 and 30 mL × minute |
| Registration number . | Study design . | Population . |
|---|---|---|
| ND high-risk MM | ||
| NCT03104842 | Isatuximab-KRd as induction, consolidation, and maintenance | Transplant eligible or ineligible del(17p) in ≥10% of purified cells and/or t(4;14) and/or >3 copies +1q21 ISS II or III |
| NCT03756896 | Carfilzomib, pomalidomide, and dexamethasone as maintenance after HDM-ASCT | Transplant eligible achieving at least partial response Presence of del(17p), t(4;14), t(14;16), t(14;20) PCL at diagnosis |
| NCT04025450 | Chidamide (HDAC inhibitor)–lenalidomide, bortezomib, and dexamethasone as induction | Transplant eligible and ineligible Presence of del(17p), t(4;14), t(14;16), t(14;20) R-ISS III IgD/IgE Extramedullary plasmacytomas Peripheral plasma cells by flow cytometry ≥0.165% |
| NCT02128230 | Induction with melphalan 20–KTD-PACE followed by melphalan 80–KTd-PACE plus ASCT and KTD-PACE consolidation and KRd maintenance (1 year) and Kd (1 year) | Transplant eligible GEP70 risk score of ≥0.66 |
| NCT03549442 | BCMA CAR-T + huCART19 in different schedules | ISS III or R-ISS III or Metaphase karyotype with >3 abnormalities except hyperdiploidy Failure to achieve partial response or better to initial therapy based on PI and IMiD |
| NCT04196491 | BCMA CAR-T bb2121 (ide-cel) (150-800 × 106) followed by lenalidomide as maintenance | R-ISS III |
| NCT04436029 | Autologous CD8+ T cells expressing an anti-BCMA chimeric antigen receptor | High-risk patients who completed pretransplant induction antimyeloma treatment |
| NCT04133636 | BCMA CAR-T JNJ-68284528 (cilta-cel) followed by lenalidomide maintenance | Less than complete response after first-line treatment and transplant followed or not by consolidation |
| NCT04133636 | BCMA CAR-T JNJ-68284528 (cilta-cel) followed by lenalidomide and daratumumab maintenance | Noneligible for transplant patients with ISS III |
| Relapsed-refractory high-risk MM | ||
| NCT03601078 | BCMA CAR-T bb2121 (150-450 × 106) | R-ISS III and PD <18 months after the first-line treatment including induction, transplant, and lenalidomide maintenance PD <18 months since date of start initial therapy, which must contain PI, IMiD, and dexamethasone Less thanVGPR after induction, including PI, IMiD, and dexamethasone and transplant (between 70 and 110 days after transplant) |
| NCT04133636 | BCMA CAR-T JNJ-68284528 (cilta-cel) | One prior line including PI, IMiD, and PD within the first 12 months after transplant or the first-line treatment for nontransplant eligible |
| NCT03104270 | Elotuzumab in combination with pomalidomide, carfilzomib, and dexamethasone | More than 2 prior lines, including PI and IMiD and del(17p), t(14;16), t(14:20) PCL Extramedullary disease Doubling in levels of MM markers in the past 3 months Refractoriness to their most recent lenalidomide-containing regimen and PI-based regimen Renal failure with CrCl between 15 and 30 mL × minute |
cilta-cel, ciltacabtagene autoleucel; CrCL, creatinine clearance; GEP70, gene expression profiling-70; HDAC, histone deacetylase; ide-cel, idecabtagene vicleucel; IMiD, immunomodulatory drug; Kd, carfilzomib and dexamethasone; KRd, carfilzomib, lenalidomide and dexamethasone; KTD-PACE, carfilzomib, thalidomide, dexamethasone, cisplatin, doxorubicin, cyclophosphamide, and etoposide; PD, progression disease; VGPR, very good partial response.