Select Ongoing Trials Currently Enrolling Patients with Multiple Myeloma

The following clinical trials represent a selection of key studies currently recruiting patients with multiple myeloma for inclusion in investigations of new therapies and new regimens of existing treatments for the disease. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. This information can help oncology practice managers and providers direct eligible patients to one of these clinical trials.


1 Daratumumab/rHuPH20plus Lenalidomide versus Lenalidomide Alone as Maintenance Therapy Post-ASCT in Multiple Myeloma

The purpose of this randomized, parallel-assignment, phase 3 study is to evaluate the efficacy and safety of the combination of daratumumab (Darzalex) and recombinant human hyaluronidase PH20 (rHuPH20) plus lenalidomide (Revlimid) versus lenalidomide alone as 2-year maintenance therapy after autologous stem-cell transplant (ASCT) in patients with multiple myeloma. Patients aged 18 to 75 years who have initiated induction therapy within 12 months before step 2 of registration and who have received ≥2 cycles of induction therapy; who have adequate hepatic, renal, and bone marrow function; have had completed ASCT within 180 days of registration; and whose ASCT-related toxicities have recovered to grade ≤1 may be eligible if other criteria are met. Eligible patients will be randomized to receive either lenalidomide or lenalidomide plus daratumumab/rHuPH20 for up to 2 years, and minimal residual disease (MRD) status will guide further therapy. MRD-positive patients will continue with the assigned treatment and MRD-negative patients will be further randomized to either continue or discontinue the assigned treatment.

The primary outcome measure is overall survival (OS) from date of initial randomization until death due to any cause, assessed up to 15 years. Secondary outcome measures include progression-free survival (PFS) from date of initial randomization until progression or death due to any cause, assessed up to 7 years; partial response per the International Uniform Response Criteria for Multiple Myeloma; and MRD negativity for 24 months from initial randomization. The study plans to enroll 1100 participants throughout the United States and worldwide. For more information, contact Sandi Hita, JD, at 1-210-614-8808 or This email address is being protected from spambots. You need JavaScript enabled to view it., or Dana Sparks, MAT, at 1-210-614-8808 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04071457.


2 Bortezomib, Lenalidomide, and Dexamethasone with or without Ciltacabtagene Autoleucel Followed by Lenalidomide and Dexamethasone in Newly Diagnosed Multiple Myeloma

The purpose of this randomized, parallel-assignment, open-label, phase 3 study is to compare the combination of bortezomib (Velcade), lenalidomide, and dexamethasone with ciltacabtagene autoleucel versus the combination therapy alone followed by lenalidomide and dexamethasone therapy in patients with newly diagnosed multiple myeloma for whom ASCT is not initial therapy. Patients aged ≥18 years with a diagnosis of multiple myeloma as per the International Myeloma Working Group (IMWG) diagnostic criteria, who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and whose disease is not considered for high-dose chemotherapy with ASCT due to advanced age, presence of comorbid conditions likely to have a negative impact on tolerability of high-dose chemotherapy plus ASCT, or deferral of high-dose chemotherapy with ASCT as initial treatment may be eligible if other criteria are met. Eligible patients will receive the combination therapy for 6 cycles before randomization, then be randomized to receive either 2 more cycles of the combination treatment followed by lenalidomide and dexamethasone maintenance therapy or apheresis followed by 8 cycles of the combination treatment followed by the conditioning regimen and ciltacabtagene autoleucel.

The primary outcome measure is PFS from the date of randomization to the date of first documented progressive disease, as defined in the IMWG criteria, or death due to any cause. Secondary outcome measures include sustained MRD-negative complete response, overall MRD-negative complete response, OS, complete response or stringent complete response, time to subsequent antimyeloma therapy, change in baseline in health-related quality of life as assessed by the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC-QLQ-C30) score, and time to worsening of symptoms, functioning, and overall well-being. Secondary outcome measures for patients in the second arm include systemic cytokine concentrations, level of chimeric antigen receptor T-cell activation markers, level of soluble B-cell maturation antigen and B-cell maturation antigen expressing cells, and number of patients with presence of replication competent lentivirus. The study plans to enroll 650 patients throughout the United States and worldwide. For more information, contact Janssen Research & Development Clinical Trials at 1-844-434-4210 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04923893.


3 Belantamab Mafodotin versus Pomalidomide plus Low-Dose Dexamethasone in Relapsed or Refractory Multiple Myeloma

The purpose of this randomized, parallel-assignment, open-label, multicenter, phase 3 study is to evaluate the efficacy and safety of belantamab mafodotin (Belamaf) versus pomalidomide (Pomalyst) plus low-dose dexamethasone in patients with relapsed or refractory multiple myeloma. Patients aged ≥18 years with an ECOG performance status of 0-2, who have a histologic or cytologic confirmed diagnosis of multiple myeloma as per IMWG criteria, have had ASCT or are ASCT-ineligible, have received ≥2 previous lines of antimyeloma treatments that included 2 consecutive cycles of lenalidomide and a proteasome inhibitor, and who have documented disease progression on, or within 60 days of, completion of last treatment, as defined by IMWG, may be eligible if other criteria are met. Eligible patients will be randomized to receive belantamab mafodotin 2.5 mg/kg intravenously on day 1 every 3 weeks, or pomalidomide 4 mg daily by mouth (PO) on days 1 to 21 of each 28-day cycle plus dexamethasone 40 mg PO once weekly or 20 mg PO once weekly on days 1, 8, 15, and 22.

The primary outcome measure is PFS from date of randomization until earliest date of documented disease progression as per the IMWG response criteria, or death due to any cause. Secondary outcome measures include OS, overall response rate (ORR), clinical benefit rate, duration of response (DOR), number of patients with adverse events (AEs), number of patients with antidrug antibodies against belantamab mafodotin, EORTC-QLQ-C30 score, and rate of MRD. The study plans to enroll 380 patients throughout the United States and worldwide. For more information, contact the US GSK Clinical Trials Call Center at 1-877-379-3718 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04162210.


4 Ixazomib Citrate plus Lenalidomide versus Lenalidomide Alone in Patients with Residual Multiple Myeloma

The purpose of this randomized, parallel-assignment, double-blind, phase 3 study is to evaluate the efficacy of ixazomib citrate (Ninlaro) plus lenalidomide versus lenalidomide alone in the treatment of patients with residual multiple myeloma after ASCT. Patients aged ≥18 years with multiple myeloma who have been receiving lenalidomide maintenance therapy for 10 to 15 months after early ASCT and are not on other current chemotherapy or ancillary investigational therapy, who have an ECOG performance status of 0-2, have not been on systemic treatment within 14 days before the first dose of ixazomib citrate with strong CYP3A inducers or use St. John’s wort, and who agree to register into the mandatory Risk Evaluation and Mitigation Strategies program may be eligible if other criteria are met. Eligible patients will be randomized to receive lenalidomide PO daily on days 1 to 28 and ixazomib citrate PO on days 1, 8, and 15 of each cycle, or lenalidomide PO daily plus placebo on days 1, 8, and 15.

The primary outcome measures include OS, change in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Trial Outcome Index score, and change in Functional Assessment of Cancer Therapy-Multiple Myeloma Trial Outcome Index score. Secondary outcome measures include PFS, MRD, incidence of AEs, best response to treatment as per IMWG criteria, DOR, time to progression, treatment duration, patient-reported outcomes as per the Common Terminology Criteria for Adverse Events, and dose intensity. The study plans to enroll 510 patients throughout the United States and worldwide. For more information, contact Shaji K. Kumar, MD, at This email address is being protected from spambots. You need JavaScript enabled to view it., or the recruiting sites directly. The NLM identifier is NCT03941860.


5 Standard Therapy versus Idecaptagene Vicleucel in Relapsed or Refractory Multiple Myeloma

The purpose of this randomized, parallel-assignment, multicenter, open-label, phase 3 study is to compare the efficacy and safety of idecaptagene vicleucel (Abecma) versus standard therapy in patients with relapsed or refractory multiple myeloma. Patients aged ≥18 years with documented diagnosis of multiple myeloma and measurable disease, who have received 2 to 4 previous multiple myeloma regimens, including previous treatment with daratumumab for at least 2 consecutive cycles, who have achieved a response to at least 1 previous treatment regimen, have an ECOG performance status of 0 or 1; and who were refractory to their last treatment regimen may be eligible if other criteria are met. Eligible patients will be randomized to receive idecaptagene vicleucel 150-450 × 106 chimeric antigen receptor T-cells after lymphodepleting chemotherapy, or standard regimens as per investigator’s discretion.

The primary outcome measure is PFS from time at randomization to the first documentation of progressive disease, based on the IMWG criteria. Secondary outcome measures include OS, event-free survival, ORR, MRD, complete response rate, DOR, time to response, AEs, EORTC-QLQ-C30, time to next antimyeloma treatment, and PFS after next line therapy. The study plans to enroll 381 patients throughout the United States and worldwide. For more information, contact Associate Director Clinical Trial Disclosure at 1-888-260-1599, or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT03651128.


6 Venetoclax and Dexamethasone versus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

The purpose of this randomized, parallel, open-label, multicenter phase 3 study is to compare the safety and efficacy of venetoclax (Venclexta) plus dexamethasone versus pomalidomide plus dexamethasone in patients with translocation t(11;14)-positive relapsed or refractory multiple myeloma. Patients aged ≥18 years who have translocation t(11;14)-positive multiple myeloma and have had ≥2 previous lines of therapy, have received ≥2 consecutive cycles of lenalidomide therapy and are relapsed or refractory to lenalidomide, who have received ≥2 consecutive cycles of proteasome inhibitor, and who have an ECOG performance status ≤2 may be eligible if other criteria are met. Eligible patients will be randomized to receive venetoclax PO daily plus dexamethasone PO weekly for each 28-day cycle, or pomalidomide PO daily on days 1 to 21 of each 28-day cycle plus dexamethasone PO weekly.

The primary outcome measure is PFS from time of randomization to the date of first documented progressive disease or death due to any cause, whichever comes first. Secondary outcome measures include ORR, OS, DOR, time to disease progression, MRD negativity rate, and very good partial response or better response rate. The study plans to enroll 244 patients throughout the United States and worldwide. For more information, contact the AbbVie Call Center at 1-844-663-3742 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT03539744.


7 Ixazomib, Lenalidomide, and Dexamethasone Combination in Multiple Myeloma Previously Treated with Bortezomib-Based Induction Regimen

The purpose of this open-label, single-arm, multicenter study is to evaluate the effectiveness and safety of ixazomib (Ninlaro) in combination with lenalidomide and dexamethasone in patients with multiple myeloma who previously received a bortezomib-based induction regimen. Patients aged ≥18 years with multiple myeloma as per current IMWG diagnostic criteria who have completed 3 cycles of bortezomib-based induction regimen and have no evidence of disease progression, who are transplant ineligible or do not expect to have transplantation for at least 24 months after study enrollment, and who have an ECOG performance status of 0-2 may be eligible if other criteria are met. Eligible patients will receive ixazomib 4 mg PO once daily on days 1, 8, and 15; lenalidomide 25 mg PO once daily on days 1 to 21; and dexamethasone 40 mg PO once on days 1, 8, 15, and 22 of a 28-day cycle for a maximum of 39 cycles until progressive disease or unacceptable toxicity, whichever occurs first, for up to 3 years.

The primary outcome measure is PFS from date of first administration of study drug regimen to date of first documentation of progressive disease or death due to any cause, whichever comes first. Secondary outcome measures include DOR; duration of therapy; relative dose intensity for each study drug; percentage of patients with partial response, very good partial response, and complete response; and duration of ixazomib therapy. The study plans to enroll 160 patients throughout the United States. For more information, contact the Takeda Study Registration Call Center at 1-866-835-2233 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT03173092.


8 Carfilzomib, Lenalidomide, and Dexamethasone Combination Once Weekly versus Twice Weekly in Relapsed or Refractory Multiple Myeloma

The purpose of this randomized, open-label, phase 3 study is to compare once-weekly carfilzomib (Kyprolis), lenalidomide, and dexamethasone combination to twice weekly in patients with relapsed or refractory multiple myeloma. Patients aged ≥18 years with documented relapsed or progressive multiple myeloma after their last treatment, who have received 1 to 3 previous lines of therapy, have had previous treatment with a lenalidomide- and dexamethasone-containing therapy without disease progression in the first 3 months after, and have an ECOG performance status of 0-2 may be eligible if other criteria are met. Eligible patients will be randomized to receive the combination treatment once weekly with carfilzomib 56 mg/m2 intravenously over 30 minutes on days 1, 8, and 15 of each 28-day cycle, or the combination treatment twice weekly with carfilzomib 27 mg/m2 intravenously over 10 minutes on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle.

The primary outcome measure is ORR, defined as the proportion of best overall response of stringent complete response, complete response, very good partial response, and partial response per IMWG criteria. Secondary outcome measures include PFS, patient-reported convenience, incidence of treatment-emergent AEs, DOR, OS, MRD negativity rate, physical functioning and role functioning as per EORTC-QLQ-C30, and treatment satisfaction as measured by the Satisfaction with Therapy subscale of the Cancer Therapy Satisfaction Questionnaire. The study plans to enroll 460 patients throughout the United States and worldwide. For more information, contact the Amgen Call Center at 1-866-572-6436 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT03859427.

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