"A Phase 3 Randomized Study Comparing JNJ-79635322 versus Teclistamab in Participants with Relapsed or Refractory Multiple Myeloma after 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Antibody and Lenalidomide"
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase III
PATOLOGÍA
Leucemia mieloide aguda, Enfermedad de células falciformes, Linfoma Folicular, Micosis Fungoide, Trasplante de progenitores hematopoyéticos, Terapia celular y T-CARs, --> Otros, Mieloma Múltiple y otras gammapatías, Linfoma no Hodgkin, Linfoma
CENTRO INVESTIGADOR
H.U. Quirónsalud Madrid
INVESTIGADOR PRINCIPAL
Carmen Martinez-Chamorro
CENTRO INVESTIGADOR
H.U. 12 de Octubre
INVESTIGADOR PRINCIPAL
Joaquin Martinez
FECHA DE APERTURA
Julio, 2026
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
1. At the time of informed consent, be 18 years of age or at least the legal age of majority in the jurisdiction in which the study is taking place.
2. Documented diagnosis of MM as defined by the criteria below: a. MM diagnosis according to the IMWG diagnostic criteria (Rajkumar 2014) b. Measurable disease at screening as assessed by central laboratory, defined by any of the following: i. Serum M-protein level 0.5 g/dL; or ii. Serum Ig FLC 10 mg/dL and abnormal serum Ig kappa lambda FLC ratio; or iii. Urine M-protein level 200 mg/24 hours
3. Received 1 to 3 prior lines of antimyeloma therapy, including an anti-CD38 antibody and lenalidomide. The participant must have undergone at least 2 consecutive cycles of an anti-CD38 antibody at the approved dosing schedule (or a minimum of 6 doses if the anti-CD38 antibody was only part of a maintenance regimen) in any prior line and 2 consecutive cycles of lenalidomide in any prior line, unless PD was the best response to the line of therapy
4. Relapsed or refractory disease as defined below: i. Relapsed disease is defined as an initial response to prior treatment, followed by confirmed PD by IMWG response criteria >60 days after cessation of treatment. ii. Refractory disease is defined as failure to achieve a response or confirmed PD by IMWG response criteria during previous treatment or 60 days after cessation of treatment.
5. Have an ECOG performance status of 0 to 2 at screening and immediately before the first dose of study medication
2. Documented diagnosis of MM as defined by the criteria below: a. MM diagnosis according to the IMWG diagnostic criteria (Rajkumar 2014) b. Measurable disease at screening as assessed by central laboratory, defined by any of the following: i. Serum M-protein level 0.5 g/dL; or ii. Serum Ig FLC 10 mg/dL and abnormal serum Ig kappa lambda FLC ratio; or iii. Urine M-protein level 200 mg/24 hours
3. Received 1 to 3 prior lines of antimyeloma therapy, including an anti-CD38 antibody and lenalidomide. The participant must have undergone at least 2 consecutive cycles of an anti-CD38 antibody at the approved dosing schedule (or a minimum of 6 doses if the anti-CD38 antibody was only part of a maintenance regimen) in any prior line and 2 consecutive cycles of lenalidomide in any prior line, unless PD was the best response to the line of therapy
4. Relapsed or refractory disease as defined below: i. Relapsed disease is defined as an initial response to prior treatment, followed by confirmed PD by IMWG response criteria >60 days after cessation of treatment. ii. Refractory disease is defined as failure to achieve a response or confirmed PD by IMWG response criteria during previous treatment or 60 days after cessation of treatment.
5. Have an ECOG performance status of 0 to 2 at screening and immediately before the first dose of study medication
CRITERIOS DE EXCLUSIÓN
1. Serious underlying medical conditions, such as: i. Evidence of active systemic viral, fungal or bacterial infection requiring systemic antiviral, antifungal, or antimicrobial therapy. ii. Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of treatment. EXCEPTION: Participants with vitiligo, Type 1 diabetes, or prior autoimmune thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing are eligible regardless of when these conditions were diagnosed. iii. Overt clinical evidence of dementia or altered mental status
5. Presence of any of the following: i. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM). ii. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy. iii. Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than MM. The only allowed exceptions are malignancies treated within the last 24 months that are considered cured: i. Non-muscle invasive bladder cancer (solitary Ta-papillary urothelial neoplasm of low malignant potential or low-grade, <3 cm, no carcinoma in situ). ii. Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone. iii. Non-invasive cervical cancer. iv. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer (anti-hormonal therapy is permitted). v. Localized prostate cancer (M0, N0) with a Gleason Score 7, treated locally only (radical prostatectomy/radiotherapy/focal treatment). vi. Other malignancy that is considered cured with minimal risk of recurrence in consultation with the sponsor.
9. Active hepatitis of infectious origin. i. Seropositive for hepatitis B: defined by a positive test for HBsAg. Participants with resolved infection (ie, participants who are HBsAg negative with positive antibodies to total HBc antigen [anti-HBc]) must be screened using RT-PCR measurement of HBV DNA levels. Those who are RT-PCR positive will be excluded. Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by RT-PCR (see Section 10.6). ii. Known hepatitis C infection or positive serologic testing for HCV (anti-HCV) antibody. Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is obtained at screening or within 3 months prior to first dose of study treatment. iii. Other clinically active liver disease of infectious origin
10. Concurrent use of any other anticancer treatment (including non-palliative radiotherapy) or investigational agent. For participants who received an allogeneic stem cell transplant, the transplant must be dated at least 6 months before first dose of study drug. Participants who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks before the start of study treatment administration without signs of graft-versus-host disease. Toxicity related to prior anticancer treatment must have resolved to Grade 1 or better.
11. Received prior or concurrent exposure to T-cell redirecting therapy (eg, CAR-T, bispecific antibodies), directed at BCMA or GPRC5D.
5. Presence of any of the following: i. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM). ii. Any history of malignancy, other than MM, that is considered at high risk of recurrence requiring systemic therapy. iii. Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than MM. The only allowed exceptions are malignancies treated within the last 24 months that are considered cured: i. Non-muscle invasive bladder cancer (solitary Ta-papillary urothelial neoplasm of low malignant potential or low-grade, <3 cm, no carcinoma in situ). ii. Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone. iii. Non-invasive cervical cancer. iv. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer (anti-hormonal therapy is permitted). v. Localized prostate cancer (M0, N0) with a Gleason Score 7, treated locally only (radical prostatectomy/radiotherapy/focal treatment). vi. Other malignancy that is considered cured with minimal risk of recurrence in consultation with the sponsor.
9. Active hepatitis of infectious origin. i. Seropositive for hepatitis B: defined by a positive test for HBsAg. Participants with resolved infection (ie, participants who are HBsAg negative with positive antibodies to total HBc antigen [anti-HBc]) must be screened using RT-PCR measurement of HBV DNA levels. Those who are RT-PCR positive will be excluded. Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by RT-PCR (see Section 10.6). ii. Known hepatitis C infection or positive serologic testing for HCV (anti-HCV) antibody. Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is obtained at screening or within 3 months prior to first dose of study treatment. iii. Other clinically active liver disease of infectious origin
10. Concurrent use of any other anticancer treatment (including non-palliative radiotherapy) or investigational agent. For participants who received an allogeneic stem cell transplant, the transplant must be dated at least 6 months before first dose of study drug. Participants who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks before the start of study treatment administration without signs of graft-versus-host disease. Toxicity related to prior anticancer treatment must have resolved to Grade 1 or better.
11. Received prior or concurrent exposure to T-cell redirecting therapy (eg, CAR-T, bispecific antibodies), directed at BCMA or GPRC5D.
DESCRIPCIÓN
To compare the efficacy of JNJ-79635322 with teclistamab
PALABRAS CLAVE
bispecific antibody, blastic plasmacytoid dendritic cell neoplasm (bpdcn), cutaneous t-cell lymphoma, diffuse large b-cell lymphoma (dlbcl), diffuse large b-cell lymphoma (dlbcl) activated b-cell type, diffuse large b-cell lymphoma (dlbcl) germinal center b-cell type, diffuse large b-cell lymphoma (dlbcl), non germinal center b-cell type, gammapatia monoclonal, hematopoietic stem cell transplant, high-grade b-cell lymphoma, langerhans cell histiocytosis, mantle cell lymphoma, monoclonal gammopathy, multiple myeloma, myeloma, non germinal center b-cell type, non-langerhans cell histiocytosis, primary diffuse large b-cell lymphoma (dlbcl) of the central nervous system, primary mediastinal (thymic) large b-cell lymphoma, sickle cell disease, stem cell, t-cell lymphoma
