Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PLD · 1 trial · 1 indication
MTD determined via the number of dose-limiting toxicities (DLTs) per cohort for the following ixazomib- containing combinations: bortezomib+ cyclophosphamide + dexamethasone, bortezomib + cyclophosphamide + ascorbic acid, bortezomib + PLD + dexamethasone
Occurrence of adverse events throughout the study, graded via CTCAE v 4.03 criteria
Complete response (CR)+ very good partial response (VGPR) + partial response (PR), defined using IMWG criteria
CBR=ORR + minor response (MR)
| Arm | Type | Description |
|---|---|---|
| bortezomib + melphalan + prednisone | EXPERIMENTAL | Ixazomib will be administered PO at 4 mg on Days 1, 8 and 15 of a 28-day cycle. All other agents will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed. Patients that were on a 21-day cycle schedule will follow a 28-day cycle schedule and receive ixazomib on days 1, 8 and 15. Other drugs will be administered on the same days as they were given on their prior 21-day cycle schedule, except that, in the new 28-day schedule, day 1 of other drugs will be the same as day 1 of ixazomib. |
| bortezomib + dexamethasone | EXPERIMENTAL | Ixazomib will be administered PO at 4 mg on Days 1, 8 and 15 of a 28-day cycle. All other agents will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed. Patients that were on a 21-day cycle schedule will follow a 28-day cycle schedule and receive ixazomib on days 1, 8 and 15. Other drugs will be administered on the same days as they were given on their prior 21-day cycle schedule, except that, in the new 28-day schedule, day 1 of other drugs will be the same as day 1 of ixazomib. |
| carfilzomib + dexamethasone | EXPERIMENTAL | Ixazomib will be administered PO at 4 mg on Days 1, 8 and 15 of a 28-day cycle. All other agents will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed. Patients that were on a 21-day cycle schedule will follow a 28-day cycle schedule and receive ixazomib on days 1, 8 and 15. Other drugs will be administered on the same days as they were given on their prior 21-day cycle schedule, except that, in the new 28-day schedule, day 1 of other drugs will be the same as day 1 of ixazomib. |
| bortezomib + lenalidomide + dexamethasone | EXPERIMENTAL | Ixazomib will be administered PO at 4 mg on Days 1, 8 and 15 of a 28-day cycle. All other agents will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed. Patients that were on a 21-day cycle schedule will follow a 28-day cycle schedule and receive ixazomib on days 1, 8 and 15. Other drugs will be administered on the same days as they were given on their prior 21-day cycle schedule, except that, in the new 28-day schedule, day 1 of other drugs will be the same as day 1 of ixazomib. |
| carfilzomib + lenalidomide + dexamethasone | EXPERIMENTAL | Ixazomib will be administered PO at 4 mg on Days 1, 8 and 15 of a 28-day cycle. All other agents will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed. Patients that were on a 21-day cycle schedule will follow a 28-day cycle schedule and receive ixazomib on days 1, 8 and 15. Other drugs will be administered on the same days as they were given on their prior 21-day cycle schedule, except that, in the new 28-day schedule, day 1 of other drugs will be the same as day 1 of ixazomib. |
| bortezomib + cyclophosphamide + dexamethasone | EXPERIMENTAL | MTD determination. Ixazomib will be administered on Days 1, 8 and 15 of a 28-day cycle at a starting dose of 3 mg in Cycle 1, and then intra-patient dose-escalation will proceed to 4 mg in Cycle 2. All other agents will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed. Patients that were on a 21-day cycle schedule will follow a 28-day cycle schedule and receive ixazomib on days 1, 8 and 15. Other drugs will be administered on the same days as they were given on their prior 21-day cycle schedule, except that, in the new 28-day schedule, day 1 of other drugs will be the same as day 1 of ixazomib. |
| bortezomib + cyclophosphamide + ascorbic acid | EXPERIMENTAL | MTD determination. Ixazomib will be administered on Days 1, 8 and 15 of a 28-day cycle at a starting dose of 3 mg in Cycle 1, and then intra-patient dose-escalation will proceed to 4 mg in Cycle 2. All other agents will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed. Patients that were on a 21-day cycle schedule will follow a 28-day cycle schedule and receive ixazomib on days 1, 8 and 15. Other drugs will be administered on the same days as they were given on their prior 21-day cycle schedule, except that, in the new 28-day schedule, day 1 of other drugs will be the same as day 1 of ixazomib. Due to a potential drug-drug interaction between ixazomib and ascorbic acid, patients will receive ixazomib in the clinic in the morning and will be instructed to take ascorbic acid in the evening, followed by cyclophosphamide. |
| bortezomib + PLD + dexamethasone | EXPERIMENTAL | MTD determination. Ixazomib will be administered on Days 1, 8 and 15 of a 28-day cycle at a starting dose of 3 mg in Cycle 1, and then intra-patient dose-escalation will proceed to 4 mg in Cycle 2. All other agents will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed. Patients that were on a 21-day cycle schedule will follow a 28-day cycle schedule and receive ixazomib on days 1, 8 and 15. Other drugs will be administered on the same days as they were given on their prior 21-day cycle schedule, except that, in the new 28-day schedule, day 1 of other drugs will be the same as day 1 of ixazomib. |
| bortezomib + pomalidomide + dexamethasone | EXPERIMENTAL | Ixazomib will be administered PO at 4 mg on Days 1, 8 and 15 of a 28-day cycle. All other agents will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed. Patients that were on a 21-day cycle schedule will follow a 28-day cycle schedule and receive ixazomib on days 1, 8 and 15. Other drugs will be administered on the same days as they were given on their prior 21-day cycle schedule, except that, in the new 28-day schedule, day 1 of other drugs will be the same as day 1 of ixazomib. |
| carfilzomib + pomalidomide + dexamethasone | EXPERIMENTAL | Ixazomib will be administered PO at 4 mg on Days 1, 8 and 15 of a 28-day cycle. All other agents will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed. Patients that were on a 21-day cycle schedule will follow a 28-day cycle schedule and receive ixazomib on days 1, 8 and 15. Other drugs will be administered on the same days as they were given on their prior 21-day cycle schedule, except that, in the new 28-day schedule, day 1 of other drugs will be the same as day 1 of ixazomib. |
| Name | Type | Description |
|---|---|---|
| Melphalan | DRUG | Melphalan will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient). |
| Prednisone | DRUG | Prednisone will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient). |
| Cyclophosphamide | DRUG | Cyclophosphamide will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient). |
| Dexamethasone | DRUG | Dexamethasone will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient). |
| Ascorbic acid | DIETARY_SUPPLEMENT | Vitamin C will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient). |
| PLD | DRUG | Pegylated liposomal doxorubicin will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient). |
| Lenalidomide | DRUG | Lenalidomide will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient). |
| Pomalidomide | DRUG | Pomalidomide will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient). |
Key Inclusion Criteria: 1. Male or female patients 18 years or older 2. Patients must have a diagnosis of MM, based on standard criteria as follows: * Major criteria: 1. plasmacytomas on tissue biopsy 2. bone marrow plasmacytosis (greater than 30% plasma cells) 3. monoclonal imm...
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PLD is an investigational small molecule being studied for the treatment of Multiple Myeloma. It is currently in Phase 1 clinical development. The drug is being evaluated in a completed clinical trial that enrolled 45 patients with Multiple Myeloma in the United States.
The specific molecular target of PLD has not been disclosed. PLD is a small molecule therapeutic being investigated for Multiple Myeloma. Its mechanism of action is not publicly detailed in available clinical trial information.
PLD is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker symbol TAK. Takeda is conducting clinical research on PLD for the treatment of Multiple Myeloma.
PLD is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. A Phase 1 clinical trial for PLD in Multiple Myeloma has been completed.
PLD has been studied in one clinical trial, identified as NCT02206425, titled "Ixazomib as a Replacement for Carfilzomib and Bortezomib for Multiple Myeloma Patients." This Phase 1 study was completed and enrolled 45 participants in the United States.
PLD is not the same as Ixazomib. The clinical trial NCT02206425 evaluates Ixazomib as a replacement for other proteasome inhibitors in Multiple Myeloma patients. PLD is a separate investigational drug being developed by Takeda.