Trials for Patients with Multiple Myeloma

The following clinical trials are currently recruiting patients with multiple myeloma for inclusion in several investigations. Each trial description includes the NLM Identifier to use as a reference with ClinicalTrials.gov.

1 Clinical and Molecular Observational Study

This prospective, longitudinal, observational study aims to identify the molecular profiles and clinical characteristics that define subsets of patients with multiple myeloma. Patients who are aged ?18 years, newly diagnosed with symptomatic multiple myeloma, treatment-naïve but eligible for systemic treatment, and ?30 days from their baseline bone marrow evaluation may be eligible for this study if other criteria are met.

Primary outcome measures for this study are molecular profiles and clinical characteristics at initial diagnosis and relapse, as measured by standard clinical and laboratory assessments. Genomic tests on bone marrow aspirates will be performed at baseline, suspected complete response, and relapse or progression. Secondary outcome measures include rates of survival measured 5 to 8 years from baseline, radiographically assessed bone disease, and health-related quality of life. It is expected this study will enroll 1000 patients at multiple locations throughout the United States.

For more information, contact Auclair Daniel at 203-652-0218 or This email address is being protected from spambots. You need JavaScript enabled to view it., or the CoMMpass Contact Center at This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01454297.

2 TH-302 plus Dexamethasone

This open-label, nonrandomized, parallel-assignment, phase 1/2 study assesses the safety, tolerability, and preliminary efficacy of TH-302 (a hypoxia-activated pro­drug) plus dexamethasone with or without bortezomib in the treatment of patients with relapsed or refractory multiple myeloma. Patients who are aged ?18 years and whose disease has relapsed or is refractory to ?2 therapies may be eligible to enroll if other criteria are met.

Primary objectives of this study include the determination of safety and tolerability, dose-limiting toxicities, and maximum tolerated dose as well as a recommended phase 2 dosing of TH-302 plus dexamethasone with or without bortezomib in patients with relapsed or refractory multiple myeloma. As part of the study’s secondary objectives, investigators will assess preliminary efficacy of the study drugs as well as progression-free survival.

This study is expected to enroll 60 patients at sites throughout the United States. For more information, contact Stephanie Mar at 650-474-8221 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01522872.

3 CB-5083 for Relapsed or Refractory Multiple Myeloma

This nonrandomized, single-group, open-label study seeks to determine the safety, tolerability, dose-limiting toxicities, and maximum tolerated dose of CB-5083 in the treatment of patients with relapsed or refractory multiple myeloma. Patients with an Eastern Cooperative Oncology Group performance status score of ?2 who are aged ?18 years and who have adequate organ and cardiac function may be eligible to enroll if other criteria are met. Eligible patients will receive oral CB-5083 as a single agent, and may then receive CB-5083 combined with a low dose of oral dexamethasone if their disease progresses after 2 cycles.

Primary outcome measures are the dose-limiting toxicities, pharmacokinetic profile, and safety and tolerability of oral CB-5083. Secondary outcome measures include the pharmacokinetic and pharmacodynamic profiles of CB-5083, and the antitumor activity of oral CB-5083 in patients with measurable disease.

This study is expected to enroll 50 patients in California, Missouri, New Jersey, and Georgia. For more information, contact Alessandra Cesano, MD, PhD, at 650-443-3019 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02223598.

4 Osteocytes in Bone Disease

Investigators in this exploratory, observational, case-control study hope to compare the serum FGF23, heparanase, Dickkopf1, and plasma klotho levels of patients with relapsed or newly diagnosed multiple myeloma with those of healthy controls. Patients who are aged ?18 years, are not pregnant, and do not have a history of malignancy in the past 5 years—except for basal-cell and squamous-cell carcinoma of the skin—may be eligible to enroll if other criteria are met. Healthy participants will have their blood drawn, and patients with multiple myeloma will have their blood drawn in addition to bone marrow aspirations.

Primary outcome measures are the molecular reactions between osteocytes and multiple myeloma, and secondary outcome measures include correlating FGF23, heparanase, Dickkopf1, and plasma klotho to tumor staging and the extent of bone resorption.

This study is expected to enroll 240 patients in Indianapolis, IN. For more information, contact Attaya Suvannasankha, MD, at 317-278-9306 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02212262.

5 Siltuximab for High-Risk Smoldering Multiple Myeloma

This phase 2, randomized, double-blind, placebo-controlled study seeks to evaluate the safety and efficacy of siltuximab in the treatment of patients with high-risk smoldering multiple myeloma. Patients who are aged ?18 years with a diagnosis of smoldering multiple mye­loma for <4 years and an Eastern Cooperative Oncology Group performance status score of ?1 may be eligible to enroll if other criteria are met. Patients will receive either siltuximab or placebo intravenously every 4 weeks until their disease progresses to symptomatic multiple myeloma, toxicity becomes unacceptable, they withdraw their consent, or the end of the study is reached.

The primary outcome measure is 1-year progression-free survival, measured from 6 months after randomization of the last patient. Secondary outcome measures include progression-free survival, changes in clinical laboratory values, and overall survival, all of which are assessed 4 years after the last patient is randomized.

This study is expected to enroll 74 patients at multiple locations across the United States and abroad. For more information, contact Janssen Research & Development at This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01484275.

6 Panobinostat for Relapsed and Relapsed/Refractory Disease

This phase 1, open-label study evaluates panobinostat in combination with lenalidomide, bortezomib, and dexamethasone for the treatment of patients with multiple myeloma. Patients who are aged ?18 years with relapsed or relapsed/refractory multiple myeloma after receiving ?2 lines of therapy, and an Eastern Cooperative Oncology Group performance status score of <2 may be eligible to enroll if other criteria are met. Treatment cycles will last 21 days, and participants will be expected to visit the clinic on days 1, 4, 5, 8, 10, and 11 during the first cycle, and on days 1, 4, 8, and 11 during the second and later cycles. Drugs include oral panobinostat, subcutaneous injections of bortezomib, oral lenalidomide, and oral dexamethasone.

Primary outcome measures are the maximum tolerated dose of panobin­ostat in combination with lenalidomide, bortezomib, and dexamethasone, and the recommended dose of the combination for future phase 2 studies. Secondary outcome measures are progression-free survival, duration of response, and response to the treatment over a time frame of 2 years.

This study is expected to enroll 28 patients in Boston, MA, and Durham, NC. For more information, contact Jacob Laubach, MD, at 617-632-4218 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01965353.

7 Ricolinostat with or without Bortezomib and Dexamethasone

Investigators in this open-label, phase 1/2 study seek to determine the side effects and most effective dose of oral ricolinostat as monotherapy and in combination with bortezomib and dexamethasone (phase 1), as well as the objective response rate of ricolinostat in combination with bortezomib and dexamethasone (phase 2) in the treatment of patients with relapsed or relapsed/refractory multiple myeloma. Patients who are aged ?18 years with adequate renal and hepatic function and a Karnofsky Performance Status score of ?70 may be eligible to enroll if other criteria are met. Patients will receive a liquid oral dose of ricolinostat on days 1 to 5 and 8 to 12 of a 21-day treatment cycle.

Primary outcome measures are the maximum tolerated dose and objective response rates of ricolinostat monotherapy and in combination with bortezomib and dexamethasone, and secondary outcome measures include characterizing the safety, determining the single- and multiple-dose pharmacokinetics, and evaluating the pharmacodynamics of ricolinostat with or without bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma.

For more information, contact Gina Leone at 617-245-1300 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01323751.

8 Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes

This nonrandomized, open-label study aims to determine the side effects and safest maximum dose of tumor-associated antigen (TAA)specific cytotoxic T-lymphocytes (CTLs), and to determine whether this therapy is effective in the treatment of patients with multiple mye­loma. Patients who are aged ?18 years with a life expectancy of ?6 weeks and a Karnofsky Performance Status score of ?50 may be eligible to enroll if other criteria are met. Patients will receive TAA-specific CTLs as therapy for multiple mye­loma, or TAA-specific CTLs as adjunctive therapy for patients with multiple myeloma following autologous or syngeneic transplant.

The primary outcome measure is the number of patients with adverse events, which will assist in determining the safety of 2 intravenous injections of autologous TAA-specific CTLs in this patient population. Secondary outcome measures include expansion and persistence of the CTLs at 1 year, and reduction of multiple myeloma over a time frame of 8 weeks.

This study is expected to enroll 36 patients in Houston, TX. For more information, contact Rammurti Kamble, MD, at 713-441-1450 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02291848.

9 Ricolinostat with Pomalidomide and Low-Dose Dexamethasone

Investigators in this open-label, nonrandomized, phase 1/2 study seek to determine the maximum tolerated dose, safety, and efficacy of ricolino­stat in the treatment of patients with relapsed and refractory multiple myeloma. Patients who are aged ?18 years with measurable levels of myeloma paraprotein in serum (?0.5 g/dL), and an Eastern Cooperative Oncology Group performance status score of ?2 may be eligible to enroll if other criteria are met. Patients will receive ricolinostat in combination with pomalidomide and dexamethasone over a 28-day cycle.

Primary outcome measures are the maximum tolerated dose, dosing schedule, and overall response rate of ricolinostat in combination with pomalidomide and low-dose dexamethasone. Secondary outcome measures include safety (assessed by type, frequency, and severity of adverse events, and the relationship of adverse events to the study drug) and efficacy (assessed by time to response, duration of response, time to progression, progression-free survival, and objective response).

The study is expected to enroll 100 patients at multiple locations throughout the United States. For more information, contact Gretchen Patrick at 617-245-1319 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01997840.

10 ?CART-19 T-Cells for Multiple Myeloma

The purpose of this study is to determine the safety, tolerability, and engraftment potential of chimeric antigen receptor-19 (CART-19) T-cells in the treatment of patients with multiple myeloma who are undergoing salvage autologous stem-cell transplantation (ASCT) following early relapse after their first transplant procedure. Patients who are aged ?18 years, have undergone previous ASCT for multiple myeloma but have progressed within 365 days of stem-cell infusion, and have an absolute bone marrow plasma cell percentage ?10% may be eligible to enroll if other criteria are met. Primary outcome measures are the number of adverse events over a 2-year time frame.

The study is expected to enroll 15 patients in Philadelphia, PA. For more information, contact Edward Stadtmauer, MD, at 855-216-0098 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02135406.

11Oral LGH447 for Relapsed and/or Refractory Disease

Investigators in this phase 1, open-label, nonrandomized study seek to estimate the maximum tolerated dose and/or recommended dose for expansion of LGH447 as a single agent for once-daily oral administration in the treatment of adult patients with multiple myeloma. Patients who are aged ?18 years with confirmed diagnoses of multiple myeloma that is relapsed and/or refractory, and an Eastern Cooperative Oncology Group performance status score of ?2 may be eligible to enroll if other criteria are met. Patients in the first treatment arm will receive oral LGH447 until disease progression or unacceptable toxicity occurs, and patients in the second treatment arm will receive midazolam on 2 separate days—with the first dose administered before the start of LGH447 and the second dose coadministered with LGH447—and continue to receive oral LGH447 until disease progression or unacceptable toxicity occurs.

Primary outcome measures are to estimate the maximum tolerated dose and/or recommended dose for expansion of LGH447 as a single agent. Secondary outcome measures include antimyeloma activity associated with LGH447, the number of participants with adverse events and serious adverse events, and the pharmacokinetic and pharmacodynamic effects of LGH447.

The study is expected to enroll 77 patients at multiple locations throughout the United States and abroad. For more information, contact Novartis Pharmaceuticals at 888-669-6682. The NLM Identifier is NCT01456689.

12 Pomalidomide, Marizomib, and Dexamethasone for Relapsed or Refractory Disease

This phase 1, open-label trial seeks to evaluate the 3-drug combination of pomalidomide, marizomib, and dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma. Patients who are aged ?18 years, and who have previously received ?1 lines of antimyeloma therapy with both lenalidomide and bortezomib—either separately or combined—may be eligible to enroll if other criteria are met. During a 28-day cycle, patients will receive oral pomalidomide on days 1 to 21; intravenous marizomib on days 1, 4, 8, and 11; and oral dexamethasone on days 1, 2, 4, 5, 8, 9, 11, 12, 15, 16, 22, and 23.

Primary outcome measures are to determine the maximum tolerated dose and/or the recommended doses for future phase 2 studies of this 3-drug combination. Secondary outcome measures are adverse events and response rates for a time frame of ?5 years.

This study is expected to enroll 36 patients at multiple locations throughout the United States and abroad. For more information, contact Mohit Trikha, PhD, at 858-242-1508 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02103335.

Related Articles

Subscribe to
Oncology Practice Management

Stay up to date with oncology news & updates by subscribing to recieve the free OPM print publications or weekly e‑Newsletter.

I'd like to recieve: