Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as JNJ-79635322
Ramantamig · 7 trials · 5 indications
PFS is defined as the duration from randomization to either confirmed progression of disease (PD) or death, whichever occurs first.
12-month MRD-negative CR rate is defined as participants who achieve MRD-negative status at 12 months (+/-3 months) from randomization, as determined by next-generation sequencing (NGS), prior to PD or subsequent antimyeloma therapy (including ASCT). Additionally, participant must achieve CR or better any time from randomization up to and including 12+3 months prior to PD or subsequent antimyeloma therapy, according to international myeloma working group (IMWG) criteria.
CR or better is defined as the percentage of participants achieving CR or stringent complete response (sCR) prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria during or after the study treatment.
Overall response is defined as having achieved partial response (PR) or better, according to the international myeloma working group (IMWG) response criteria, as assessed any time after first administration of study treatment, but prior to progression of disease (PD) or subsequent antimyeloma therapy.
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 first ramantamig dose will be reported.
DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
An AE is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.
Participants with clinically significant laboratory abnormalities (hematology and chemistry) will be reported.
An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.
Number of participants with abnormalities in laboratory values (hematology and chemistry) 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: JNJ-79635322 | EXPERIMENTAL | Participants will receive subcutaneous (SC) dose of JNJ-79635322 treatment of a finite duration or intolerable toxicity (whichever is first). |
| Arm B: Teclistamab | ACTIVE_COMPARATOR | Participants will receive teclistamab as a SC injection until PD or intolerable toxicity. |
| JNJ-79635322 | EXPERIMENTAL | Participants will receive subcutaneous (SC) dose of JNJ-79635322 until progressive disease (PD) or intolerable toxicity. |
| Anti BCMAxCD3 Bispecific Antibody | ACTIVE_COMPARATOR | Participants will receive teclistamab (an Anti BCMAxCD3 bispecific anitbody) as a SC injection until PD or intolerable toxicity. |
| Arm A: Tocilizumab + Ramantamig | EXPERIMENTAL | Participants will receive tocilizumab along with 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) along with ramantamig. Ramantamig will be administered for a total treatment of finite duration, or until PD or intolerable toxicity (whichever is earlier). |
| Treatment Regimen A and C: JNJ-79635322+Daratumumab | EXPERIMENTAL | Participants who have received 1-3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) (Treatment regimen A1 and A3) will receive JNJ-79635322 along with daratumumab to establish the recommended phase 2 doses (RP2D\[s\]) of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Based on the study evaluation team (SET) decision, enrollment may proceed in participants with newly diagnosed multiple myeloma (NDMM) (Treatment regimens A2, A4 and C). Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens. |
| Treatment Regimen B: JNJ-79635322+Pomalidomide | EXPERIMENTAL | Participants who have received greater than or equal to (\>=)1 prior line of therapy, including a PI and lenalidomide, and are lenalidomide refractory or \>=2 prior lines of therapy, including a PI and lenalidomide will receive JNJ-79635322 along with pomalidomide to establish the RP2D(s) of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens. |
| Treatment Regimen D and E: JNJ-79635322 + Daratumumab + Lenalidomide Combination | EXPERIMENTAL | Participants with NDMM will receive JNJ-79635322 along with daratumumab and lenalidomide to establish the RP2D\[s\] of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 combination treatment regimen(s) at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens. |
| Treatment Regimen F: JNJ-79635322 + Daratumumab | EXPERIMENTAL | Participants with newly diagnosed amyloid light chain (ND AL) amyloidosis will receive JNJ-79635322 in treatment regimen F along with daratumumab to establish the RP2D\[s\] of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 and daratumumab at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens. |
| Treatment Regimen G: JNJ-79635322 + Daratumumab | EXPERIMENTAL | Participants with high-risk smoldering multiple myeloma (SMM) will receive JNJ-79635322 in treatment regimen G along with daratumumab to establish the RP2D\[s\] of the JNJ-79635322 during Part 1 (Dose Escalation) of the study. Dose escalation and de-escalation will be based on SET evaluation. In Part 2 (Dose Expansion) participants will receive a dose of JNJ-79635322 and daratumumab at the RP2D(s) determined in Part 1 and in disease subgroup(s) to determine the safety and tolerability of the combination treatment regimens. |
| Part 1: Dose Escalation | EXPERIMENTAL | Participants will receive JNJ-79635322. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified. |
| Part 2: Dose Expansion | EXPERIMENTAL | Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1. |
| 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. |
| JNJ-79635322 | DRUG | JNJ-79635322 will be administered as SC injection. |
| Teclistamab | DRUG | Teclistamab will be administered as SC injection. |
| Tocilizumab | DRUG | Tocilizumab will be administered as intravenous (IV) injection. |
| Placebo | DRUG | Placebo (saline) will be administered as IV injection. |
| Pomalidomide | DRUG | Pomalidomide will be administered orally. |
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, a cancer of plasma cells in the bone marrow. It is in Phase 3 development and is being evaluated in newly diagnosed multiple myeloma and in relapsed or refractory multiple myeloma. It is not yet approved for any use.
Ramantamig is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. Johnson & Johnson is the sponsor of the clinical trials evaluating the drug in multiple myeloma.
Ramantamig is in Phase 3 clinical development for multiple myeloma. It is an investigational small molecule and has not been approved by the FDA or any other regulatory agency. Two trials are currently recruiting participants, one Phase 3 study and one Phase 2 study.
Ramantamig is being evaluated in two recruiting trials. NCT07665450 is a Phase 3 study of Ramantamig plus daratumumab versus DVRd or DRd in newly diagnosed multiple myeloma for participants not planning a stem cell transplant, enrolling about 1,000 people. NCT07589634 is a Phase 2 study of prophylactic tocilizumab with Ramantamig in relapsed or refractory multiple myeloma, enrolling about 230 people.
The two recruiting Ramantamig trials have a combined planned enrollment of approximately 1,230 participants. The Phase 3 study NCT07665450 plans to enroll about 1,000 participants, and the Phase 2 study NCT07589634 plans to enroll about 230 participants. Both are randomized, double-blind, and placebo-controlled.
The Phase 3 Ramantamig trial NCT07665450 is running in France, Greece, Israel, the Netherlands, Poland, South Korea, Spain, Turkey, and the United Kingdom. The Phase 2 trial NCT07589634 is running in the United States, Argentina, Australia, France, Greece, Malaysia, Portugal, Spain, and Sweden. Both enroll adults aged 18 years and older.