Select Clinical Trials Currently Enrolling Patients with Multiple Myeloma

March 2017, Vol 7, No 3 - Clinical Trials Tracker


The following clinical trials represent a selection of key studies that are currently recruiting patients with multiple myeloma for inclusion in investigations of new therapies or new regimens of existing treatments for patients with multiple myeloma. Each 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 an appropriate clinical trial.

1 Efficacy and Safety of Bendamustine, Dexamethasone, and Thalidomide in Relapsed or Refractory Multiple Myeloma

This prospective, open-label, single-group assignment, multicenter, phase 2 clinical trial is designed to determine the efficacy and safety of a combination chemotherapy consisting of bendamustine plus dexamethasone and thalidomide in patients with multiple myeloma after treatment with lenalidomide and bortezomib or who are ineligible for one of these drugs. Men and women aged ≥18 years with a life expec­tancy of ≥3 months and with an Eastern Cooperative Oncology Group (ECOG) performance status of <2 at study entry, unless it results from multiple myeloma, may be eligible for enrollment if other criteria are met. Eligible patients will receive bendamustine plus dexamethasone and thalidomide.

The primary outcome measures are the assessment of response and safety assessment. The secondary outcome measure is survival. This study plans to enroll 30 patients in Italy. For more information, contact Michael Mian, MD, at michael.mian@asbz.it. The NLM Identifier is NCT01526694.

2 Elotuzumab plus Pomalidomide, Bortezomib, and Dexamethasone in Relapsed Multiple Myeloma

This open-label, single-group assignment, phase 2 study is studying a combination of elotuzumab, pomalidomide, bortezomib, and dexamethasone as a possible treatment for relapsed or refractory multiple myeloma. Men and women aged ≥18 years with previously treated relapsed or refractory multiple myeloma and an ECOG performance status of ≤2 may be eligible for enrollment if other criteria are met. Participants will receive elotuzumab in combination with pomalidomide, bortezomib, and dexamethasone. The primary outcome measures are overall response rate and the number of participants with treatment-related adverse events. The secondary outcome measure is progression-free survival. This study expects to enroll 46 patients in Massachusetts. For more information, contact Andrew J. Yee, MD, at 617-724-4000 or ayee1@mgh.harvard.edu. The NLM Identifier is NCT02718833.

3 Lenalidomide, Subcutaneous Bortezomib, and Dexamethasone for Newly Diagnosed Multiple Myeloma

The purpose of this open-label, single-group assignment, phase 2 clinical trial is to evaluate a combination of lenalidomide, subcutaneous bortezomib, and dexamethasone as a possible treatment for multiple myeloma. Men and women aged ≥18 years with clonal plasma cells of >10% on bone marrow biopsy and with an ECOG performance status of ≤2 may be eligible for enrollment if other criteria are met. Patients will receive bortezomib, lenalidomide, and dexamethasone.

The primary outcome measure is overall response rate. The secondary outcome measures include the time to disease progression, progression-free survival, duration of response, and overall response. This study plans to enroll 45 patients at multiple locations across the United States. For more information, contact Jacob Laubach, MD, at 617-582-7102 or jacobp_laubach@dfci.harvard.edu. The NLM Identifier is NCT02441686.

4 Effect of Ibrutinib in Patients with High-Risk Smoldering Multiple Myeloma

This open-label, single-group assignment, phase 2 clinical trial assesses whether ibrutinib is effective at preventing multiple myeloma in people who currently have smoldering multiple myeloma. Men and women aged ≥18 years with high-risk smoldering multiple myeloma and with an ECOG performance status of <2 may be eligible for enrollment if other criteria are met. Eligible patients will receive ibrutinib.

The primary outcome measure is the number of participants with symptomatic multiple myeloma. The secondary outcome measures are the overall response rate and changes in bone density, PET-MRI, serum interleukin-6, serum stromal cell–derive factor-1, serum receptor activator of nuclear-factor kappa B ligand, serum macrophage inflammatory protein-1 alpha, serum Dickkopf-1, serum c-terminal telopeptide, and in urine N-terminal telopeptide. This study plans to enroll 36 patients in New York. For more information, contact Lisa La, MS, at 212-241-7873 or lisa.la@mssm.edu, or Ajai Chari, MD, at 212-241-7873 or ajai.chari@mountsinai.org. The NLM Identifier is NCT02943473.

5 Daratumumab, Lenalidomide, and Dexamethasone versus Lenalidomide and Dexamethasone in Patients with Previously Untreated Multiple Myeloma

This randomized, parallel-assignment, phase 3 clinical trial will compare the efficacy of daratumu­mab plus lenalidomide and dexamethasone with lenalidomide and dexamethasone in terms of progression-free survival in participants with newly diagnosed multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem-cell transplant (ASCT). Men and women aged ≥18 years with an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Patients will receive daratumumab plus lenalidomide and dexamethasone or lenalidomide and dexamethasone.

The primary outcome measure is progression-free survival. The secondary outcome measures include time to disease progression, percentage of patients with complete response, minimal residual disease, progression-free survival on next line of therapy, overall survival, stringent complete response, time to next treatment, overall response, very good partial response, time to response, duration of response, and quality of life. This study expects to enroll 730 patients at multiple locations across the United States and abroad. For more information, e-mail JNJ.CT@sylogent.com. The NLM Identifier is NCT02252172.

6 Daratumumab plus Bortezomib, Melphalan, and Prednisone versus Bortezomib plus Melphalan and Prednisone in Previously Untreated Multiple Myeloma

The purpose of this randomized, parallel-assignment, phase 3 clinical trial will determine whether the addition of daratumumab to bortezomib plus melphalan and prednisone will prolong progression-free survival compared with bortezomib plus melphalan and prednisone in participants with previously untreated multiple myeloma who are ineligible for high-dose chemotherapy and ASCT. Men and women aged ≥18 years with an ECOG performance status of 0 to 2 and who meet the clinical laboratory criteria as specified in the protocol may be eligible for enrollment if other criteria are met. Eligible patients will receive daratumumab plus bortezomib, melphalan, and prednisone or bortezomib plus melphalan and prednisone.

The primary outcome measure is progression-free survival. The secondary outcome measures are time to disease progression, complete response, minimal residual disease, progression-free survival on next line of therapy, time to next treatment, overall response rate, stringent complete response, very good partial response, time to response, duration of response, overall survival, perception of global health, and clinical efficacy in high-risk molecular subgroups. This study plans to enroll 700 patients at multiple locations across the United States and abroad. For more information, e-mail JNJ.CT@sylogent.com. The NLM Identifier is NCT02195479.

7 Carfilzomib, Lenalidomide, Dexamethasone versus Lenalidomide Alone After Stem-Cell Transplantation for Multiple Myeloma

This randomized, open-label, parallel-assignment, phase 3 study will evaluate carfilzomib, lenalidomide, and dexamethasone versus lenalidomide alone after stem-cell transplantation for multiple myeloma. Men and women aged ≥18 years with an ECOG performance status of 0 or 1 and with adequate hepatic function may be eligible for enrollment if other criteria are met. Eligible patients will receive carfilzomib plus lenalidomide and dexamethasone versus lenalidomide alone.

The primary objective is to assess progression-free survival. The secondary objectives are to determine the rate of minimal residual disease and to compare the efficacy rate. This study plans to enroll 180 patients at the University of Chicago. For more information, contact Jennifer Nam at 773-702-7716 or jnam@medicine.bsd.uchicago.edu. The NLM Identifier is NCT02659293.

8 Venetoclax in Patients Receiving Bortezomib and Dexamethasone As Standard Therapy

The purpose of this phase 3, randomized, parallel-assignment, double-blind study is to evaluate the efficacy and safety of venetoclax plus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma who are considered sensitive or naïve to proteasome inhibitors and who have received 1 to 3 previous lines of therapy for multiple myeloma. Men and women aged ≥18 years with an ECOG performance status of ≤2 may be eligible for enrollment if other criteria are met. Eligible patients will receive venetoclax plus bortezomib and dexamethasone or placebo plus bortezomib and dexamethasone.

The primary outcome measure is progression-free survival. The secondary outcome measures include very good partial response, progression-free survival, duration of response, overall survival, time to disease progression, objective response rate, minimal residual disease status, pain inventory, quality of life, and patient-reported outcomes. This study plans to enroll 240 patients at multiple locations across the United States and abroad. For more information, contact AbbVie Call Center at 847-283-8955. The NLM Identifier is NCT02755597.

9 Nivolumab, Elotuzumab, Pomalidomide, and Dexamethasone in Multiple Myeloma: the CheckMate 602 Study

The purpose of this randomized, crossover assignment, phase 3 clinical trial is to evaluate the clinical benefit and safety of the combination therapy of nivolumab, pomalidomide, and dexamethasone compared with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. The study includes a third arm evaluating the clinical benefit and the safety of the combination therapy of elotuz­umab, nivolumab, pomalidomide, and dexamethasone in the same patient population. Patients in the control arm are allowed to cross over to the exploratory arm at the time of disease progression. Men and women aged ≥18 years with relapsed or refractory multiple myeloma and who had received at least 2 previous lines of therapy may be eligible for enrollment if other criteria are met. Eligible patients will receive nivolumab, pomalidomide, and dexamethasone or pomalidomide and dexamethasone. Patients will be allowed to cross over to nivolumab, elotuzumab, pomalidomide, and dexamethasone on disease progression.

The primary outcome measures are objective response rate and progression-free survival. The secondary outcome measures are time to objective response, duration of objective response, investigator-assessed progression-free survival, and investigator-assessed objective response rate. This study plans to enroll 406 patients at multiple locations across the United States and abroad. For more information, e-mail Clinical.Trials@bms.com. The NLM Identifier is NCT02726581.

10 Tandem Autologous Stem-Cell Transplantation with Melphalan Followed by Melphalan and Bortezomib in Patients with Multiple Myeloma

This phase 3, nonrandomized, open-label, single-group assignment is assessing the efficacy and safety of ASCT with melphalan followed by melphalan and bortezomib in patients with multiple myeloma. Men and women aged 18 to 75 years with a confirmed diagnosis of multiple myeloma and with a Karnofsky performance status of 70% to 100% may be eligible for enrollment if other criteria are met. Eligible patients will receive hematopoietic ASCT with melphalan, followed by melphalan and bortezomib.

The primary outcome measure is progression-free survival. The secondary outcome measures are response rate, overall survival, and regimen-related toxicities. This study expects to enroll 110 patients at the Hackensack University Medical Center, NJ. For more information, contact Michele Donato, MD, at MDonato@humed.com. The NLM Identifier is NCT01241708.

11 Pomalidomide and Low-Dose Dexamethasone with or without Pembrolizumab in Refractory or Relapsed and Refractory Multiple Myeloma

The purpose of this randomized, parallel-assignment, open-label, phase 3 clinical trial is to compare the efficacy of pomalidomide and low-dose dexamethasone with pembrolizumab with that of pomalidomide and low-dose dexamethasone without pembrolizumab in terms of progression-free survival in participants with refractory or relapsed and refractory multiple myeloma who have undergone at least 2 previous lines of treatment. Men and women aged ≥18 years with a confirmed diagnosis of active multiple myeloma and measurable disease and with an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive pembrolizumab plus pomalidomide and dexamethasone or pomalidomide plus dexamethasone.

The primary outcome measures are progression-free survival and overall survival. The secondary outcome measure is overall response rate. This study expects to enroll 300 patients at multiple locations across the United States and abroad. For more information, call 888-577-8839. The NLM Identifier is NCT02576977.

12 Pomalidomide and Low-Dose Dexamethasone with or without Elotuzu­mab for Refractory and Relapsed and Refractory Multiple Myeloma: the ELOQUENT-3 Clinical Trial

The purpose of this randomized, parallel-assignment, phase 2 clinical trial is to determine whether adding elotuzumab to pomalidomide and low-dose dexamethasone is more effective for relapsed and refractory multiple myeloma than pomalidomide and low-dose dexamethasone alone. Men and women aged ≥18 years with at least 2 lines of therapy and with an ECOG performance status of ≤2 may be eligible for enrollment if other criteria are met. Eligible patients will receive pomalidomide plus low-dose dexamethasone and elotuzumab or pomalidomide plus low-dose dexamethasone.

The primary outcome measure is progression-free survival. The secondary outcome measures include objective response rate and overall survival. This study expects to enroll 121 patients at multiple locations across the United States and abroad. For more information, e-mail Clinical.Trials@bms.com. The NLM Identifier is NCT02654132.

13 Melflufen plus Dexamethasone in Relapsed or Refractory Multiple Myeloma: the HORIZON Clinical Trial

This single-group assignment, open-label, phase 2 clinical trial will evaluate melflufen in combination with dexamethasone for relapsed or refractory multiple myeloma in adults with disease that is refractory to pomalidomide and/or daratumu­mab. Men and women aged ≥18 years with a life expectancy of ≥6 months and with an ECOG performance status of ≤2 may be eligible for enrollment if other criteria are met. Patients will receive melflufen plus dexamethasone.

The primary outcome measure is the overall response rate. The secondary outcome measures include progression-free survival, duration of response, and overall survival. This study expects to enroll 78 patients at multiple locations across the United States and abroad. For more information, contact Eva Nordstrom, PhD, at eva.nordstrom@oncopeptides.se, or Jakob Lindberg, MLic, BA, at jakob.lindberg@oncopeptides.se. The NLM Identifier is NCT02963493.

14 Clarithromycin plus Cyclophosphamide, Thalidomide, and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma

This randomized, open-label, parallel-assignment, phase 3 clinical trial assesses whether clarithromycin could potentiate the responsiveness of cyclophosphamide, thalidomide, and dexamethasone in newly diagnosed multiple myeloma. Men and women aged ≥18 years with active multiple myeloma and with a Karnofsky performance status ≥50 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive clarithromycin plus cyclophosphamide, thalidomide, and dexamethasone or cyclophosphamide plus thalidomide and dexamethasone.

The primary outcome measure is the percentage of patients with very good partial remission. The secondary outcome measures include median progression-free survival, 2-year overall survival, and the number of participants with adverse events. This study expects to enroll 130 patients in China. For more information, contact Yongping Zhai at ypzhai@medmail.com.cn. The NLM Identifier is NCT02248428.