Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ramantamig · 2 trials · 1 indication
PFS is defined as the time from treatment assignment (that is, randomization in the trial) to confirmed progression of disease (PD) or death, whichever occurs first.
12-month MRD-negative CR rate is defined as achieving MRD-negative status at the analysis time window of 12 months (+/-3 months), as determined by next-generation sequencing (NGS) with sensitivity of 10\^-5, prior to PD or subsequent antimyeloma therapy (including ASCT). Additionally, CR or better must be achieved any time from randomization up to and including 12+3 months, according to international myeloma working group (IMWG) criteria.
Percentage of participants alive and free of treatment-emergent ASTCT Grade \>=2 CRS without the use of intervening treatment for CRS of any grade by the end of Day 28 from ramantamig dose will be reported.
| Arm | Type | Description |
|---|---|---|
| Arm A: Ramantamig plus Daratumumab (Ramantamig-D) | EXPERIMENTAL | Participants will receive ramantamig D subcutaneous injection. |
| Arm B: Investigator's Choice (DVRd or DRd) | ACTIVE_COMPARATOR | Participants will receive either daratumumab, bortezomib, lenalidomide, dexamethasone (DVRd) or daratumumab, lenalidomide, dexamethasone (DRd) as per investigator's choice. |
| Arm A: Tocilizumab + Ramantamig | EXPERIMENTAL | Participants will receive tocilizumab alongwith ramantamig. Ramantamig will be administered for a total treatment of finite duration, or until progressive disease (PD) or intolerable toxicity (whichever is earlier). |
| Arm B: Placebo + Ramantamig | PLACEBO_COMPARATOR | Participants will receive placebo (saline) alongwith ramantamig. Ramantamig will be administered for a total treatment of finite duration, or until PD or intolerable toxicity (whichever is earlier). |
| Name | Type | Description |
|---|---|---|
| Ramantamig | DRUG | Ramantamig will be administered subcutaneously. |
| Daratumumab | DRUG | Daratumumab will be administered subcutaneously. |
| Lenalidomide | DRUG | Lenalidomide will be administered orally. |
| Bortezomib | DRUG | Bortezomib will be administered subcutaneously or intravenously. |
| Dexamethasone | DRUG | Dexamethasone will be administered orally or intravenously. |
| Tocilizumab | DRUG | Tocilizumab will be administered as intravenous (IV) injection. |
| Placebo | DRUG | Placebo (saline) will be administered as IV injection. |
Inclusion criteria: * Documented diagnosis of multiple myeloma (MM) according to the IMWG diagnostic criteria * Not considered for high-dose chemotherapy with autologous stem cell transplantation (ASCT) due to: i. ineligible due to advanced age; or ii. ineligible due to presence of comorbid conditi...
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Ramantamig is an investigational small molecule being studied for the treatment of multiple myeloma. It is currently in Phase 3 clinical development for this indication, including a study in newly diagnosed multiple myeloma patients who are not planned for stem cell transplant.
The specific molecular target of Ramantamig has not been disclosed. It is a small molecule modality, but its mechanism of action is not publicly detailed in the available information.
Ramantamig is being developed by Johnson & Johnson, a pharmaceutical company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical trials to evaluate the drug's safety and efficacy in multiple myeloma.
Ramantamig is in Phase 3 clinical development for multiple myeloma. One Phase 3 trial is planned but not yet recruiting, and a Phase 2 trial is currently recruiting participants. The drug is investigational and has not been approved by regulatory authorities.
Ramantamig is involved in two active clinical trials. NCT07665450 is a Phase 3 study comparing Ramantamig plus daratumumab against standard regimens in newly diagnosed multiple myeloma. NCT07589634 is a Phase 2 study evaluating tocilizumab to prevent cytokine release syndrome with Ramantamig in relapsed/refractory multiple myeloma.
No, Ramantamig is not the same as daratumumab. Daratumumab is a monoclonal antibody, while Ramantamig is a small molecule. In clinical trials, Ramantamig is being studied in combination with daratumumab, indicating they are distinct agents with different mechanisms.