May 2016 VOL 7, NO 4

← Back to Issue


Clinical Trials Tracker

Select Ongoing Trials Currently Enrolling Patients with Multiple Myeloma

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

1. Ixazomib plus Lenalidomide and Dexamethasone versus Placebo plus Lenalidomide and Dexamethasone in Adult Patients with Newly Diagnosed Multiple Myeloma

This randomized, double-blind, multicenter, phase 3 clinical trial evaluates the safety and efficacy of ixazomib versus placebo when added to lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation. Men and women aged ≥18 years diagnosed with multiple myeloma according to standard criteria who have not received previous treatment with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive a combination of ixazomib plus lenalidomide and dexamethasone or placebo plus lenalidomide and dexamethasone alone.

The primary outcome measure is progression-free survival. The secondary outcome measures include complete response, overall survival, and pain response rate. This study plans to enroll 701 patients at multiple locations across the United States and abroad. For more information contact Takeda Oncology, at 877-674-3784. The NLM Identifier is NCT01850524.

2. Daratumumab plus Lenalidomide and Dexamethasone versus Lenalidomide plus Dexamethasone in Patients with Previously Untreated Multiple Myeloma

This phase 3, randomized, parallel-assignment, open-label clinical trial compares the efficacy of dara­tumumab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with newly diagnosed multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem cell transplantation. Men and women aged ≥18 years with documented multiple myeloma and calcium elevation, renal insufficiency, anemia, and bone abnormalities may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive daratum­umab plus lenalidomide and dexamethasone or lenalidomide plus dexamethasone alone.

The primary outcome measure is progression-free survival. Some of the secondary outcome measures include time to disease progression, percentage of patients with complete response, and percentage of patients with negative minimal residual disease. This study expects to enroll 730 patients at multiple locations across the United States and abroad. For more information contact JNJ.CT@sylogent.com. The NLM Identifier is NCT02252172.

3. Pomalidomide with Cyclophosphamide and Dexamethasone in Relapsed or Refrac­tory Multiple Myeloma

The purpose of this phase 2, single-group, open-label clinical trial is to assess the safety and efficacy of pomalidomide when used in combination with cyclophosphamide and dexamethasone. Men and women aged ≥18 years who have received at least 2 previous lines of therapy and whose disease is refractory to lenalidomide may be eligible for enrollment if other criteria are met. Eligible patients will receive pomalidomide in combination with cyclophosphamide and dexamethasone.

The primary outcome measure is the best overall response rate. Some of the secondary outcome measures include stringent complete response, very good partial response, time to disease progression, duration of response, progression-free survival, and overall survival. This study expects to enroll 35 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 NCT02176213.

4. Lenalidomide plus Dexamethasone with or without Elotuzumab for Patients with Newly Diagnosed Multiple Myeloma

This phase 2, randomized, open-label clinical trial compares the efficacy of lenalidomide plus dexamethasone and elotuzumab versus lenalidomide plus dexamethasone alone in patients with newly diagnosed, previously untreated multiple myeloma. Men and women aged ≥20 years with newly diagnosed, symptomatic multiple myeloma; those who have not received any previous systemic antimyeloma therapy; and patients with measurable disease may be eligible for enrollment if other criteria are met.

The primary outcome measure is objective response rate. The secondary outcome measure is the difference in the objective response rate between patients receiving lenalidomide plus dexamethasone and elotuz­umab versus those receiving lenalidomide plus dexamethasone alone. This study plans to enroll 80 patients in Japan. For more information please e-mail Clinical.Trials@bms.com. The NLM Identifier is NCT02272803.

5. Elotuzumab in Combination with Pomalidomide and Low-Dose Dexamethasone in Patients with Multiple Myeloma Relapsed or Refractory to Previous Treatment with Lenalidomide

This phase 2, multicenter, open-label, single-arm study is assessing the efficacy and safety of elotuzumab in combination with pomalidomide and low-dose dexamethasone for the treatment of patients with multiple myeloma that has relapsed after or is refractory to treatment with a lenalidomide-based regimen. Men and women aged ≥18 years with documented multiple myeloma that has relapsed after or is refractory to a previous lenalidomide-based regimen and who have an ECOG performance status of ≤2 may be eligible for enrollment if other criteria are met. Eligible patients will receive elotuzumab plus pomalidomide and low-dose dexamethasone.

The primary outcome measure is progression-free survival. The secondary outcome measures include overall response rate and overall survival rate. This study plans to enroll 60 patients at multiple locations across the United States. For more information please e-mail Clinical.Trials@bms.com. The NLM Identifier is NCT02612779.

6. Bendamustine, Bortezomib, and Prednisone for First-Line Treatment of Patients with Symptomatic Multiple Myeloma

This phase 2, open-label, single-group assignment clinical trial is evaluating the efficacy of bendamustine, bortezomib, and prednisone followed by autologous stem cell transplantation in patients with newly diagnosed multiple myeloma who are not eligible for high-dose chemotherapy. Men and women aged ≥18 years with newly diagnosed multiple myeloma requiring systemic treatment and with a World Health Organization performance status of 0 to 3 may be eligible for enrollment if other criteria are met. Eligible patients will receive a combination regimen of bendamustine, bortezomib, and prednisone.

The primary outcome measure is overall response rate. Some of the secondary outcome measures include progression-free survival, overall survival, duration of response, and toxicity. This study expects to enroll 96 patients in Germany. For more information contact Marc S. Raab, MD, at marc.raab@uni-heidelberg.de; or Wolfgang Knauf, MD, at wolfgang.knauf@telemed.de. The NLM Identifier is NCT02237261.

7. Bortezomib or Carfilzomib with Lenalidomide and Dexamethasone in Patients with Newly Diagnosed Symptomatic Multiple Myeloma

This randomized, open-label, parallel-assignment, phase 3 clinical trial compares the efficacy of bortez­omib, lenalidomide, and dexamethasone versus carfilzomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma, followed by lenalidomide maintenance therapy. Men and women aged ≥18 years with symptomatic standard-risk multiple myeloma and measurable or evaluable disease who have an ECOG performance status score of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to bortezomib, lenalidomide, and dexamethasone, or to carfilzomib, lenalidomide, and dexamethasone, followed by lenalidomide maintenance therapy every 4 weeks for 24 courses, or lenalidomide every 4 weeks.

The primary outcome measure is overall survival for the maintenance analysis. Some of the secondary outcome measures include progression-free survival for the maintenance analysis, progression-free survival for the induction analysis, and overall survival for the induction analysis. This study plans to enroll 756 patients at multiple locations across the United States. The NLM Identifier is NCT01863550.

8. Oral Ixazomib Maintenance Therapy in Patients with Multiple Myeloma Who Have Completed Initial Therapy but Not Stem Cell Transplantation

The purpose of this phase 3, randomized, placebo-controlled, double-blind clinical trial is to determine the effect of oral ixazomib maintenance therapy on progression-free survival compared with placebo in patients with newly diagnosed multiple myeloma who have had a complete response, very good partial response, or partial response to initial therapy and who have not undergone stem cell transplantation. Men and women aged ≥18 years with a confirmed diagnosis of symptomatic multiple myeloma who have completed 6 to 12 months of initial therapy and who have an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive ixazomib or placebo.

The primary outcome measure is progression-free survival. Some of the secondary outcome measures include overall survival, time to disease progression, overall survival in a high-risk population, and the time to improvement of peripheral neuropathy events. This study expects to enroll 761 patients in Redlands, CA. For more information contact the Takeda Study Registration Call Center, at 877-825-3327, or medical­information@tpna.com. The NLM Identifier is NCT02312258.

9. Carfilzomib, Lenalidomide, and Dexamethasone versus Lenalidomide Alone After Stem Cell Transplantation for Multiple Myeloma

This phase 3, randomized, open-label, parallel-assignment clinical trial is evaluating the efficacy of carfilzomib, lenalidomide, and dexamethasone versus lenalidomide alone in patients with multiple myeloma who have undergone stem cell transplantation. Men and women aged ≥18 years who have completed single autologous stem cell transplantation after ≤2 induction regimens and are in at least stable disease in the first 100 days after stem cell transplantation may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive the combination of carfilzomib, lenalidomide, and dexamethasone, or lenalidomide alone.

The primary outcome measure is time to progression or death. The secondary outcome measures include the rate of minimal residual negative disease and the efficacy rate of the combination of carfilzomib, lenalidomide, and dexamethasone versus lenalidomide alone. This study plans to enroll 180 patients in Chicago, IL. For more information contact Jennifer Nam, at 773-702-7716, or jnam@medicine.bsd.uchicago.edu. The NLM Identifier is NCT02659293.

10. Bortezomib-Melphalan Conditioning Regimen versus Melphalan for Frontline Treatment of Transplant-Eligible Patients with Multiple Myeloma

This open-label, multicenter, parallel-assignment, phase 3 clinical trial is comparing the efficacy of a combined high-dose chemotherapy using melphalan and bortezomib versus melphalan alone followed by stem cell transplantation in the frontline treatment of patients with multiple myeloma. Men and women aged 18 to 65 years with symptomatic de novo multiple myeloma, and those who are eligible for high-dose therapy with autologous stem cell transplantation, may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive bortezomib plus melphalan or melphalan alone.

The primary outcome measures are complete response rate and overall survival. The secondary outcome measures include response rate, serious adverse events, and progression-free survival. This study expects to enroll 300 patients at multiple locations in Belgium and France. For more information contact Sandrine Rollet, at Rollet.Sandrine@iuct-oncopole.fr. The NLM Identifier is NCT02197221.

11. Combination of Bortezomib, Melphalan, and Prednisone with or without Daratumumab in Treatment-Naive Patients with Multiple Myeloma

The purpose of this randomized, open-label, parallel-assignment, phase 3 clinical trial is to determine if the addition of daratumumab to a regimen of bortezomib, melphalan, and prednisone will prolong progression-free survival compared with bortezomib, melphalan, and prednisone without daratumumab. Men and women aged ≥18 years with documented multiple myeloma satisfying the calcium elevation, renal insufficiency, anemia, and bone abnormalities diagnostic criteria and who have an ECOG performance status score of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients are randomized to receive daratumumab in combination with bortezomib, melphalan, and prednisone, or bortezomib, melphalan, and prednisone alone.

The primary outcome measure is progression-free survival. Some of the secondary outcome measures include time to disease progression, the percentage of patients achieving complete response, and time to next treatment. 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.

12. Lenalidomide and Dexamethasone with or without Pembrolizumab in Patients with Newly Diagnosed, Treatment-Naive Multiple Myeloma

This randomized, open-label, parallel-assignment, phase 3 clinical trial is comparing the efficacy of lenalidomide plus low-dose dexamethasone and pembroliz­umab versus lenalidomide and low-dose dexamethasone in patients with newly diagnosed and treatment-naive multiple myeloma who are ineligible for autologous stem cell transplantation. Men and women aged ≥18 years with a confirmed diagnosis of active multiple myeloma and measurable disease who have an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive pembrolizumab plus lenalidomide and dexamethasone or lenalidomide plus dexamethasone alone.

The primary outcome measure is progression-free survival. The secondary outcome measure is overall survival. This study expects to enroll 640 patients at multiple locations in the United States and Spain. For more information contact Merck at 888-577-8839. The NLM Identifier is NCT02579863.

13. Single Autologous Stem Cell Transplantation Followed by Maintenance Therapy as Frontline Treatment for Multiple Myeloma

This open-label, single-group assignment, phase 3 clinical trial is evaluating the efficacy of single autologous hematopoietic stem cell transplantation with standard conditioning of melphalan 200 mg/m2 followed by thalidomide maintenance in patients with newly diagnosed multiple myeloma after receiving 4 to 6 cycles of induction chemotherapy consisting of vincristine, doxorubicin, and dexamethasone or of thalidomide and dexamethasone alone. Men and women aged 18 to 65 years with newly diagnosed multiple myeloma for whom stem cell transplantation is considered appropriate may be eligible for enrollment if other criteria are met. Eligible patients will receive single autologous stem cell transplantation followed by thalidomide maintenance.

The primary outcome measure is response rate. The secondary outcome measures include overall survival, progression-free survival, and toxicity. This study expects to enroll 80 patients in China. For more information contact Jiong Hu, MD, at hujiong@medmai.com.cn; or Wei Tang, MD, at weiwei_tang@yahoo.com. The NLM Identifier is NCT00892346.

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

This randomized, parallel-assignment, open-label, phase 3 clinical trial is assessing whether clarithromycin could potentiate the efficacy of a treatment regimen with cyclophosphamide, thalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma. This trial will also evaluate the side effects caused by the combination of these drugs. Men and women aged ≥18 years with previously untreated active multiple myeloma and with a Karnofsky performance status of ≥50 may be eligible for enrollment if other criteria are met. Eligible patients will receive clarithromycin in combination with thalidomide, cyclophosphamide, and dexamethasone or cyclophosphamide, thalidomide, and dexamethasone alone.

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

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

This randomized, open-label, parallel-assignment, phase 3 clinical trial is comparing the efficacy of pomalidomide plus low-dose dexamethasone and pembroliz­umab versus pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma who have undergone ≥2 lines of previous therapy. Men and women aged ≥18 years with active multiple myeloma who have undergone previous treatment with ≥2 lines of antimyeloma therapy and were refractory to the last line of treatment may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive pembrolizumab plus pomalidomide and dexamethasone or pomalidomide and dexamethasone alone.

The primary outcome measure is progression-free survival. The secondary outcome measure is overall survival. This study expects to enroll 300 patients at multiple locations in the United States and Japan. For more information contact Merck at 888-577-8839. The NLM Identifier is NCT02576977.

Related Articles
Evidence into Practice - April 29, 2016

Continuum of Care and Care Transitions

The scope of navigation has evolved from the Freeman model of community outreach and prevention to spanning the entire continuum of care for oncology patients. Navigators help individuals overcome barriers [ Read More ]

Evidence into Practice - April 29, 2016

National Cancer Institute Community Cancer Centers Program Navigation Assessment Tool

As all navigation programs are built uniquely, we encourage you to rate your program as you feel appropriate. The purpose of this form is not to gauge one program against [ Read More ]