Clinical Trials Using Anti-BCMA Antibody-drug Conjugate GSK2857916

Clinical trials are research studies that involve people. The clinical trials on this list are studying Anti-BCMA Antibody-drug Conjugate GSK2857916. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-9 of 9
  • To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed / Refractory Multiple Myeloma (RRMM)

    This study will evaluate the safety and tolerability profile of belantamab mafodotin when administered in combination with approved regimens of either Lenalidomide Plus Dexamethasone [Len / Dex (Arm A)] or Bortezomib Plus Dexamethasone [Bor / Dex (Arm B)] in participants with RRMM, i.e., those who have relapsed or who are refractory to at least 1 line of approved therapy. Part 1 of the study will be a dose escalation phase to evaluate the safety and tolerability of up to 3 dose levels and up to 2 dosing schedules of belantamab mafodotin in combination with the two standard of care (SoC) regimens. Part 2 will further evaluate the safety and preliminary clinical activity of belantamab mafodotin at selected dose levels and dosing schedules in combination with Len / Dex or Bor / Dex. A total of 152 evaluable participants will be enrolled in the study with up to 27 in Part 1 and up to 125 in Part 2. Participants receiving treatment Arm A, may continue combination treatment until the occurrence of progressive disease (PD), intolerable adverse events (AEs ), consent withdrawal, death or end of study. The participants receiving treatment Arm B, may continue combination treatment for a total of up to 8 cycles. After 8 cycles of combination therapy, the participants will continue treatment with belantamab mafodotin, as a monotherapy until the occurrence of PD, intolerable AEs, consent withdrawal, death or end of study.
    Location: 7 locations

  • Selinexor and Backbone Treatments of Multiple Myeloma Patients

    This study will independently assess the efficacy and safety of 10 combination therapies in 11 arms, in dose-escalation / -evaluation and expansion phases, for the treatment of patients with relapsed / refractory multiple myeloma (RRMM) and newly diagnosed multiple myeloma (NDMM). The combinations to be evaluated are: - Arm 1: Selinexor + dexamethasone + pomalidomide (SPd) - Arm 2: Selinexor + dexamethasone + bortezomib (SVd); enrollment complete - Arm 3: Selinexor + dexamethasone + lenalidomide (SRd) in RRMM; enrollment complete - Arm 4: Selinexor + dexamethasone + pomalidomide + bortezomib (SPVd) - Arm 5: Selinexor + dexamethasone + daratumumab (SDd); enrollment complete - Arm 6: Selinexor + dexamethasone + carfilzomib (SKd) - Arm 7: Selinexor + dexamethasone + lenalidomide (SRd) in NDMM - Arm 8: Selinexor + dexamethasone + ixazomib (SNd) - Arm 9: Selinexor + dexamethasone + pomalidomide + elotuzumab (SPEd) - Arm 10: Selinexor + dexamethasone + belantamab mafodotin (SBd) - Arm 11: Selinexor + dexamethasone + pomalidomide + daratumumab (SDPd) Selinexor pharmacokinetics: - PK Run-in (Days 1-14): Starting in protocol version 8.0, patients enrolled to any arm in the Dose Escalation Phase (i.e., Arm 4 [SPVd], Arm 6 [SKd], Arm 8 [SNd], Arm 9 [SPEd], Arm 10 [SBd], and Arm 11 [SDPd]) will also first be enrolled to a pharmacokinetics (PK) Run-in period until 9 patients have been enrolled to this period to evaluate the PK of selinexor before and after co-administration with a strong CYP3A4 inhibitor.
    Location: 7 locations

  • Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed / Refractory Multiple Myeloma

    This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib / dexamethasone (Arm A) versus daratumumab in combination with bortezomib / dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.
    Location: 5 locations

  • Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed / Refractory Multiple Myeloma (RRMM) (DREAMM 5)

    B-cell maturation antigen (BCMA) is a target present on tumor cells in participants with multiple myeloma. Belantamab mafodotin (GSK2857916); is an antibody-drug conjugate (ADC) containing humanized anti-BCMA monoclonal antibody (mAb). This is a phase I / II, randomized, open-label, platform study designed to evaluate the effects of belantamab mafodotin in combination with other anti-cancer drugs in participants with relapsed / refractory multiple myeloma. The Platform design incorporates a single master protocol, where multiple treatment combinations, as sub-studies, will be evaluated simultaneously.
    Location: 2 locations

  • Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma

    This study will evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone (VRd) and will determine recommended phase 3 dose (RP3D) in adult participants with newly diagnosed multiple myeloma (NDMM). Participants will receive the combination of bortezomib, lenalidomide and dexamethasone (VRd) on a 3-week cycle until cycle 8, followed by the combination of lenalidomide and dexamethasone (Rd) on a 4-week cycle thereafter as per dosing schedule. Participants will receive belantamab mafodotin on a schedule that is dependent on the cohort to which they are assigned. This will be every cycle of VRd, every other cycle of VRd, or every third cycle of VRd. Belantamab may also be given as a 'split' dose, which is 50% of the dose on Day 1 and 50% of the dose on Day 8 of a cycle. Participants will complete an End of Treatment (EOT) visit at the point of study treatment discontinuation, followed by a Safety Follow-up visit 70 days after EOT.
    Location: 3 locations

  • Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed / Refractory Multiple Myeloma

    This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide, bortezomib and dexamethasone (Arm B) in participants with relapsed / refractory multiple myeloma (RRMM).
    Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California

  • A Study of Belantamab Mafodotin (GSK2857916) in Multiple Myeloma Participants With Normal and Varying Degree of Impaired Renal Function

    Belantamab mafodotin (GSK2857916) is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb). Renal impairment is a major complication of multiple myeloma (MM) and majority of MM participants are either at risk or already have renal dysfunction at initial diagnosis. The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of belantamab mafodotin monotherapy in participants with RRMM, who have had at least 3 lines of prior treatment and have either normal or impaired renal functions. The study will consist of two parts: part 1 will include participants with normal / mildly impaired renal function and severe renal impairment and part 2 will include participants with end-stage renal disease (ESRD), where participants are either not undergoing or require hemodialysis. Participants will be administered GSK2857916 at a dose of 2.5 milligram per kilogram (mg / kg) intravenously once in three weeks (Q3W) dosing in Part 1. Based on the Part 1 Safety / Pharmacokinetic (PK) data, Part 2 participants will be administered the dose of either 2.5 mg / kg or 1.9 mg / kg (or other adjusted dose). Participants will be treated with GSK2857916 monotherapy until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first. This study will include a screening phase, treatment phase, and follow- up phase. The total duration of the study is approximately up to 48 months.
    Location: 3 locations

  • Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom / Dex) in Participants With Relapsed / Refractory Multiple Myeloma (RRMM)

    This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom / dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom / dex. Belantamab mafodotin will be administered intravenously at 2.5 milligram (mg) / kilogram (kg) on Day 1 (D1) of an every 3 weeks (Q3W) schedule. Pomalidomide will be administered orally at the approved starting dose of 4 mg daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered orally at a dose of 40 mg once weekly (Days 1, 8, 15, and 22). Participants in both arms will be treated until disease progression, death, unacceptable toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes first. Approximately up to 380 participants will be randomized (320 + 60 to fulfill regional country requirements).
    Location: See Clinical Trials.gov

  • A Study of Belantamab Mafodotin (GSK2857916) in Multiple Myeloma Participants With Normal and Impaired Hepatic Function

    Belantamab mafodotin (GSK2857916) is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb). Impaired hepatic function may alter the pharmacokinetics (PK) and pharmacodynamics (PD) of belantamab mafodotin, a drug that is primarily hepatically eliminated and hence may require adjustments in dosing regimens as compared to patients who have normal hepatic function. The purpose of this study is assess the PK, safety, and tolerability of belantamab mafodotin monotherapy in Relapsed / Refractory Multiple Myeloma (RRMM) participants with impaired hepatic function and in matched RRMM participants with normal hepatic function. The study will consist of two parts: Part 1 will include participants with normal hepatic function and moderate hepatic impairment and Part 2 will include participants with severe hepatic impairment. Participants will be administered GSK2857916 at a dose of 2.5 milligram per kilogram (mg / kg) intravenously in Part 1 and in Part 2, dose will depend on the evaluation of pharmacokinetic and safety data of Part 1. However, dose in Part 2 will not exceed 2.5 mg / kg. Participants will be treated with GSK2857916 monotherapy until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first. This study will include a screening phase, treatment phase and follow-up phase. The total duration of the study is approximately up to 48 months.
    Location: Northwestern University, Chicago, Illinois