BridgeMD
An Open Label Study of JNJ-68284528, Directed Against BCMA in Subjects with Multiple Myeloma
EU CTIS ID: 2023-506587-13-00
What this study is testing
To evaluate the overall minimal residual disease (MRD) negative rate of subjects who receive JNJ-68284528
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Cohort A: -1-3 prior lines of therapy, including PI and IMiD -Lenalidomide refractory -Anti-CD38 mAb exposure not required -PD per IMWG criteria ≤6 months of last regimen; confirmation may be either central or local -Prior SCT allowed (allo: >6 months before apheresis; auto: >12 weeks before apheresis)
- Cohort B: -Frontline therapy with PI and IMiD -Transplant and non-transplant patients -Anti-CD38 mAb exposure not required -PD per IMWG criteria ≤12 months of: a. Autologous SCT b. Start of initial therapy (non-transplanted patients)
- Cohort C: -Previously treated with PI, IMiD, anti-CD38 mAb and BCMA-directed therapy (as monotherapy or in combination) a. Irrespective of dose level or response to prior BCMA-directed therapy -PD per IMWG criteria a. ≤12 months of last line of therapy b. ≤6 months of prior therapy, and refractory or non-responsive to their most recent line of therapy
- Cohort A, B, C: Measurable disease at Screening as defined by any of the following: -Serum M-protein ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or -Light chain MM without measurable disease in serum or urine: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio -Central screening lab results required for all study patients: Local laboratory assessments may be used to establish measurable disease at Screening, with local laboratory result ≥125% of requirements -For subjects with neither serum nor urine measurable disease, baseline positron emission tomography/ computed tomography (PET/CT) or whole body magnetic resonance imaging (MRI) may be used to satisfy the measurable disease criteria. -Lab values as defined in the protocol
- Cohort D: -Newly diagnosed MM per IMWG with 4 to 8 total cycles of initial therapy, including induction, high-dose therapy and ASCT with or without consolidation a. Previously treated for smoldering myeloma not eligible b. Patient treated with consolidation must have received ≤2 cycles - Received IMiD or PI or both in combination with steroid as part of induction or consolidation regimen -Tx with alkylating therapy (eg, cyclophosphamide) or mAb during induction/ consolidation permitted -Labs as specified in the protocol -women of childbearing potential must follow the contraception criteria outlined in the local global REVLIMID® pregnancy prevention program or equivalent local Risk Evaluation and Mitigation Strategy (REMS), whichever is more stringent, as applicable in their region. -Men should agree to practice contraception according to and for the time frame specified in the local global REVLIMID® pregnancy prevention program or equivalent local REMS, whichever is more stringent, as applicable in their region.
- Cohort E: -Measurable disease at Screening - Documented diagnosis of MM according to IMWG criteria -Labs as specified in the protocol
You likely can't join if
- Key Exclusion criteria (All cohorts): -Antitumor treatment washout prior to apheresis -Toxicity from previous anticancer therapy must have resolved to baseline or ≤Grade 1 except alopecia or peripheral neuropathy - Serious underlying medical condition, eg: a.Clinically significant cardiac conditions (CHF, MI, LVEF <45%) b. Active / Hx of autoimmune disease within 3 yrs c. Dementia or altered mental status d. Serious viral, bacterial or uncontrolled systemic fungal infection e. Seropositive for HIV f. Clinically significant Hepatitis B or C infection - Cumulative dose of corticosteroids equivalent to ≥70 mg of prednisone ≤7 days prior to apheresis - Stroke or seizure ≤6 months - Pregnant, breast-feeding or planning to become pregnant / father child while enrolled in study and until 1 year after receiving a JNJ-68284528 infusion - Contraindications, known life threatening allergies, hypersensitivity, or intolerance to cyclophosphamide, fludarabine, or JNJ-68284528 or its excipients, including DMSO (refer to Investigator's Brochure).
- Cohort D: -Pregnant or breast-feeding, or planning to become pregnant while enrolled in this study and until 1 year after receiving a JNJ-68284528 infusion or for 4 weeks following discontinuation of lenalidomide (whichever is later). -Contraindications, known life threatening allergies, hypersensitivity, or intolerance to cyclophosphamide, fludarabine, lenalidomide, or JNJ68284528 or its excipients, including DMSO (refer to Investigator's Brochure).
- Cohort E: Contraindications, known life threatening allergies, hypersensitivity, or intolerance to boron or mannitol, hyaluronidase, sorbitol, corticosteroids, monoclonal antibodies or human proteins, cyclophosphamide, fludarabine, lenalidomide, daratumumab, bortezomib, dexamethasone, or JNJ-68284528 excipients, including DMSO. -Pregnant or breast-feeding, or planning to become pregnant while enrolled in this study and until: 1 year after receiving a JNJ-68284528 infusion, or for 4 weeks following discontinuation of lenalidomide, or until 3 months after daratumumab (whichever is later). -Plans to father a child while enrolled in this study until: 1 year after receiving a JNJ-68284528 infusion, or for 4 weeks following discontinuation of lenalidomide, or until 3 months after daratumumab (whichever is later).
- Cohort F: - Active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. - Prior therapy, prior to apheresis - Received a cumulative dose of corticosteroids equivalent to ≥70 mg of prednisone within the 7 days prior to apheresis - Ongoing toxicity from previous anticancer therapy must have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy. - Major surgery within 2 weeks prior to apheresis, or surgery planned after apheresis up to 2 weeks after cilta-cel administration. For a full list of exclusion criteria, please refer to the protocol
See the full eligibility criteria
Who can join
- Cohort A: -1-3 prior lines of therapy, including PI and IMiD -Lenalidomide refractory -Anti-CD38 mAb exposure not required -PD per IMWG criteria ≤6 months of last regimen; confirmation may be either central or local -Prior SCT allowed (allo: >6 months before apheresis; auto: >12 weeks before apheresis)
- Cohort B: -Frontline therapy with PI and IMiD -Transplant and non-transplant patients -Anti-CD38 mAb exposure not required -PD per IMWG criteria ≤12 months of: a. Autologous SCT b. Start of initial therapy (non-transplanted patients)
- Cohort C: -Previously treated with PI, IMiD, anti-CD38 mAb and BCMA-directed therapy (as monotherapy or in combination) a. Irrespective of dose level or response to prior BCMA-directed therapy -PD per IMWG criteria a. ≤12 months of last line of therapy b. ≤6 months of prior therapy, and refractory or non-responsive to their most recent line of therapy
- Cohort A, B, C: Measurable disease at Screening as defined by any of the following: -Serum M-protein ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or -Light chain MM without measurable disease in serum or urine: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio -Central screening lab results required for all study patients: Local laboratory assessments may be used to establish measurable disease at Screening, with local laboratory result ≥125% of requirements -For subjects with neither serum nor urine measurable disease, baseline positron emission tomography/ computed tomography (PET/CT) or whole body magnetic resonance imaging (MRI) may be used to satisfy the measurable disease criteria. -Lab values as defined in the protocol
- Cohort D: -Newly diagnosed MM per IMWG with 4 to 8 total cycles of initial therapy, including induction, high-dose therapy and ASCT with or without consolidation a. Previously treated for smoldering myeloma not eligible b. Patient treated with consolidation must have received ≤2 cycles - Received IMiD or PI or both in combination with steroid as part of induction or consolidation regimen -Tx with alkylating therapy (eg, cyclophosphamide) or mAb during induction/ consolidation permitted -Labs as specified in the protocol -women of childbearing potential must follow the contraception criteria outlined in the local global REVLIMID® pregnancy prevention program or equivalent local Risk Evaluation and Mitigation Strategy (REMS), whichever is more stringent, as applicable in their region. -Men should agree to practice contraception according to and for the time frame specified in the local global REVLIMID® pregnancy prevention program or equivalent local REMS, whichever is more stringent, as applicable in their region.
- Cohort E: -Measurable disease at Screening - Documented diagnosis of MM according to IMWG criteria -Labs as specified in the protocol
- Cohort F: - Documented new diagnosis of multiple myeloma according to IMWG diagnostic criteria. - Multiple myeloma classified as standard risk per International Staging System (ISS) stage I or II disease criteria - Received initial therapy as specified in protocol. Acceptable combinations include: a. daratumumab, bortezomib, lenalidomide and dexamethasone (D-VRd) or b. daratumumab, lenalidomide and dexamethasone (D-Rd) or c. a carfilzomib-based triplet or quadruplet regimen - Patient must have a documented efficacy response of VGPR or better, without Progressive Disease prior to enrollment, as assessed per IMWG 2016 criteria. - ECOG Performance Status grade of 0 or 1. For a full list of inclusion criteria, please refer to the protocol
What rules you out
- Key Exclusion criteria (All cohorts): -Antitumor treatment washout prior to apheresis -Toxicity from previous anticancer therapy must have resolved to baseline or ≤Grade 1 except alopecia or peripheral neuropathy - Serious underlying medical condition, eg: a.Clinically significant cardiac conditions (CHF, MI, LVEF <45%) b. Active / Hx of autoimmune disease within 3 yrs c. Dementia or altered mental status d. Serious viral, bacterial or uncontrolled systemic fungal infection e. Seropositive for HIV f. Clinically significant Hepatitis B or C infection - Cumulative dose of corticosteroids equivalent to ≥70 mg of prednisone ≤7 days prior to apheresis - Stroke or seizure ≤6 months - Pregnant, breast-feeding or planning to become pregnant / father child while enrolled in study and until 1 year after receiving a JNJ-68284528 infusion - Contraindications, known life threatening allergies, hypersensitivity, or intolerance to cyclophosphamide, fludarabine, or JNJ-68284528 or its excipients, including DMSO (refer to Investigator's Brochure).
- Cohort D: -Pregnant or breast-feeding, or planning to become pregnant while enrolled in this study and until 1 year after receiving a JNJ-68284528 infusion or for 4 weeks following discontinuation of lenalidomide (whichever is later). -Contraindications, known life threatening allergies, hypersensitivity, or intolerance to cyclophosphamide, fludarabine, lenalidomide, or JNJ68284528 or its excipients, including DMSO (refer to Investigator's Brochure).
- Cohort E: Contraindications, known life threatening allergies, hypersensitivity, or intolerance to boron or mannitol, hyaluronidase, sorbitol, corticosteroids, monoclonal antibodies or human proteins, cyclophosphamide, fludarabine, lenalidomide, daratumumab, bortezomib, dexamethasone, or JNJ-68284528 excipients, including DMSO. -Pregnant or breast-feeding, or planning to become pregnant while enrolled in this study and until: 1 year after receiving a JNJ-68284528 infusion, or for 4 weeks following discontinuation of lenalidomide, or until 3 months after daratumumab (whichever is later). -Plans to father a child while enrolled in this study until: 1 year after receiving a JNJ-68284528 infusion, or for 4 weeks following discontinuation of lenalidomide, or until 3 months after daratumumab (whichever is later).
- Cohort F: - Active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. - Prior therapy, prior to apheresis - Received a cumulative dose of corticosteroids equivalent to ≥70 mg of prednisone within the 7 days prior to apheresis - Ongoing toxicity from previous anticancer therapy must have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy. - Major surgery within 2 weeks prior to apheresis, or surgery planned after apheresis up to 2 weeks after cilta-cel administration. For a full list of exclusion criteria, please refer to the protocol
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Saudi Arabia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Saudi Arabia; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.