Table 1. . Immunotherapies in clinical development for the treatment of multiple myeloma.
| Therapy type | Agent/regimen | Study | Latest development stage | Number of enrolled patients | Patient population | Status |
|---|---|---|---|---|---|---|
| Vaccine | GM-CSF allogeneic vaccine | Allogeneic GM-CSF vaccine and lenalidomide in treatment myeloma patients with near complete remission (NCT01349569) | Phase II | 18 | Patients with MM near complete remission | Completed |
| KRN7000 (Alpha GalCer)-pulsed dendritic cells | Combination of lenalidomide and autologous mature dendritic cells pulsed with KRN7000 in myeloma (NCT00698776) | Phase I/II | 6 | Patients with asymptomatic MM | Completed | |
| PVX-410 multipeptide vaccine | Phase 1/2a study of cancer vaccine to treat smoldering multiple myeloma (NCT01718899) | Phase I/IIa | 22 | Patients with smoldering MM | Completed | |
| MAGE-A3 recombinant protein | MAGE-A3 protein + AS15 as consolidation for multiple myeloma patients undergoing autologous stem cell transplantation (NCT01380145) | Phase I | 13 | Patients with MM undergoing autologous SCT | Completed | |
| Checkpoint inhibitor | Pidilizumab (CT-011; anti-PD-1 antibody) + dendritic cell fusion vaccine | Blockade of PD-1 in conjunction with the dendritic cell/myeloma vaccines following stem cell transplantation (NCT01067287) | Phase II | 35 (estimated) | Patients with MM after autologous SCT | Ongoing |
| Pidilizumab (CT-011; anti-PD1 antibody) | Lenalidomide and pidilizumab in treating patients with relapsed or refractory multiple myeloma (NCT02077959) | Phase I/II | 20 | Patients with RRMM | Ongoing | |
| Pembrolizumab (anti-PD1 antibody) | A study of pembrolizumab (MK-3475) in combination with standard of care treatments in participants with multiple myeloma (MK-3475-023/KEYNOTE-023) (NCT02036502); a trial of pembrolizumab (MK-3475) in participants with blood cancers (MK-3475-013) (KEYNOTE-013) (NCT01953692) | Phase I | 115 (estimated); 222 (estimated) | Patients with MM; patients with blood cancers including MM | Ongoing; ongoing | |
| Nivolumab (anti-PD1 antibody) alone or in combination with ipilimumab (anti-CTLA-4 antibody) or lirilumab (anti-KIR antibody) | Safety study of nivolumab by Itself or in combination in patients with lymphoma or multiple myeloma (NCT01592370) | Phase I | 375 (estimated) | Patients with lymphoma or myeloma | Ongoing | |
| Cytokine-targeted agent | Siltuximab (anti-IL-6 antibody) | A study of siltuximab (anti-IL-6 monoclonal antibody) in patients with high-risk smoldering multiple myeloma (NCT01484275) | Phase II | 87 | Patients with high-risk smoldering MM | Ongoing |
| ALT-803 (IL-15 superagonist complex) | IL-15 super agonist ALT-803 to treat relapse of hematologic malignancy after allogeneic SCT (NCT01885897); QUILT-3.005: a study of ALT-803 in patients with relapsed on refractory multiple myeloma (NCT02099539) | Phase I/II | 61 (estimated); 57 (estimated) | Patients with relapse of hematologic malignancies, including MM, after allogeneic SCT; patients with RRMM | Ongoing; ongoing | |
| Adoptive T-cell transfer | CART-19 T cells targeting CD19 | CART-19 for multiple myeloma (NCT02135406) | Phase I | 13 | Patients with RRMM after autologous SCT | Ongoing |
| T cells engineered to target the NY-ESO-1 antigen | Redirected auto T cells for advanced myeloma (NCT01352286); CT antigen TCR-engineered T cells for myeloma (NCT01892293) | Phase I/II | 26 (estimated); 10 (estimated) | Patients with RRMM | Ongoing; ongoing | |
| WT1-specific donor-derived T cells | Dose escalation trial of WT1-specific donor-derived T cells following T-cell depleted allogeneic hematopoietic stem cell transplantation for patients with relapsed/refractory multiple myeloma (NCT01758328) | Phase I | 21 (estimated) | Patients with RRMM following T-cell depleted allogeneic SCT | Ongoing | |
| Natural killer cell-targeted therapy | Elotuzumab (anti-SLAMF7 antibody) | Phase III study of lenalidomide and dexamethasone with or without elotuzumab to treat newly diagnosed, previously untreated multiple myeloma (ELOQUENT - 1) (NCT01335399); Phase III study of lenalidomide and dexamethasone with or without elotuzumab to treat relapsed or refractory multiple myeloma (ELOQUENT-2) (NCT01239797) | Phase III | 750 (estimated); 761 | Patients with newly diagnosed MM; patients with RRMM | Ongoing; ongoing |
| Elotuzumab (anti-SLAMF7 antibody) in combination with lirilumab (anti-KIR antibody) or urelumab (anti-CD137 antibody) | A Phase I open label study of the safety and tolerability of elotuzumab (BMS-901608) administered in combination with either lirilumab (BMS-986015) or urelumab (BMS-663513) in subjects with multiple myeloma (NCT02252263) | Phase I | 136 (estimated) | Patients with RRMM or postautologous SCT with VGPR or CR and MRD | Ongoing | |
| Tumor-directed monoclonal antibodies | Daratumumab (anti-CD38 antibody) | Addition of daratumumab to combination of bortezomib and dexamethasone in participants with relapsed or refractory multiple myeloma (NCT02136134); a study comparing daratumumab, lenalidomide, and dexamethasone with lenalidomide and dexamethasone in relapsed or refractory multiple myeloma (NCT02076009) | Phase III | 498; 569 | Patients with RRMM | Ongoing; ongoing |
| Lorvotuzumab mertansine (anti-CD56 antibody–drug conjugate) | IMGN901 in combination with lenalidomide and dexamethasone (NCT00991562) | Phase I | 50 (estimated) | Patients with CD56+ RRMM | Completed | |
| Indatuximab ravtansine (anti-CD138 antibody–drug conjugate) | BT062 in combination with lenalidomide or pomalidomide and dexamethasone in patients with multiple myeloma (NCT01638936) | Phase I/IIa | 64 | Patients with RRMM | Ongoing | |
CAR: Chimeric antigen receptor; CR: Complete response; CTLA-4: Cytotoxic T lymphocyte–associated protein 4; GM-CSF: Granulocyte–macrophage colony-stimulating factor; IL: Interleukin; KIR: Killer-cell immunoglobulin-like receptor; MM: Multiple myeloma; MRD: Minimal residual disease; PD1: Programmed cell death 1; RRMM: Relapsed/refractory multiple myeloma; SCT: Stem cell transplant; SLAMF7: Signaling lymphocytic activation molecule family member 7; VGPR: Very good partial response.
All study details were taken from [15]