A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma

Stopped early · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

The main aims of this 3-part study are as follows: Part 1: To determine any side effects from modakafusp alfa single treatment and how often they occur. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harmful side effects is found. Part 2: To assess clinical activity of one or more dosing schedules of modakafusp alfa alone in participants with relapsed/refractory multiple myeloma. Dexamethasone standard dose will be administered with one or more selected dose of modakafusp alfa in selected group of participants. Part 3: To find the optimal dose with the more favorable risk-benefit profile of modakafusp alfa. Participants will receive modakafusp alfa at one of two doses which will be given through a vein.

Key facts

Study ID

NCT03215030

Run by

Teva Branded Pharmaceutical Products R&D LLC

People needed

272

Starts

2017-10-04

Expected to finish

2024-11-07

Last updated by the study team

2026-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For Parts 1 and 2:
• Has MM defined by the IMWG criteria with evidence of disease progression and:
• In need of additional myeloma therapy as determined by the investigator.
• Has previously received at least 3 lines of myeloma therapy (for example, containing an Immunomodulatory imide drug [IMiD], a proteasome inhibitor [PI], an alkylating agent, and/or an anti-CD38 as single agents or in combination).
• Is either refractory to or intolerant of at least 1 PI and a least 1 IMiD.
• For Part 3:
• Has MM defined by the IMWG criteria with evidence of disease progression and:
• In need of additional myeloma therapy as determined by the investigator.
• Has previously received at least 3 lines of myeloma therapy.
• Is refractory to at least 1 IMiD (ie, lenalidomide or pomalidomide [thalidomide excluded]), at least 1 PI (ie, bortezomib, ixazomib, or carfilzomib), and refractory to at least 1 anti-CD38 antibody (ie, daratumumab or isatuximab) and has demonstrated disease progression with the last therapy. Participants who are primary refractory, meaning they never achieved at least a MR with any previous treatment line, are not eligible.
• For participants in Part 2 and 3 only: Measurable disease is defined as :
• Serum M-protein ≥500 mg/dL (≥5 g/L)
• Urine M-protein ≥200 mg/24 hours.
• Serum free light chain (FLC) assay, with involved FLC level ≥10 mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal.
• During Part 1 only, participants not meeting the above criteria for measurable disease should, at least, have measurable bone marrow plasmacytosis (greater than or equal to [≥ ] 10 percent [%]) and/or plasmacytoma (≥1 centimeter [cm] in diameter) detected by physical examination or imaging.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.

You may not qualify if…

• For Parts 1 and 2:
• Has polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, solitary plasmacytoma, amyloidosis, Waldenstrom macroglobulinemia or immunoglobulin M (IgM) myeloma, or lymphoplasmacytic lymphoma (LPL).
• Who have received autologous stem cell transplant (SCT) 60 days before first infusion of modakafusp alfa or participants who have received allogeneic SCT 6 months before first infusion. Graft-versus-host disease that is active or requires ongoing systemic immunosuppression.
• Has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE less than or equal to (≤) Grade 1 or baseline, except for sensory or motor neuropathy which should have recovered to ≤ Grade 2 or baseline.
• Has clinical signs of central nervous system involvement of MM.
• For Part 3:
• Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]. Participants with resolved infection (that is, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of HBV DNA levels. Those who are PCR positive will be excluded.
• In addition to the above criteria, participants must not have plasma cell leukemia or have had primary refractory MM, current central nervous system involvement of MM, myelodysplastic syndrome, myeloproliferative syndrome, or have had a second malignancy within the previous 3 years, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, cervical carcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, or other malignancy for which the participant is not on active anticancer therapy.

Where it is running

• Los Angeles Cancer Network - Glendale Adventist Medical Center — Glendale, California, United States
• University of California Irvine — Orange, California, United States
• Office of James R. Berenson MD — West Hollywood, California, United States
• Smilow Cancer Hospital at Yale New Haven — New Haven, Connecticut, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• Northwestern Medicine - Northwestern Medical Group — Chicago, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Investigative Clinical Research of Indiana, LLC — Noblesville, Indiana, United States
• June E. Nylen Cancer Center — Sioux City, Iowa, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Univeristy of Nebraska Medical Center — Omaha, Nebraska, United States
• USOR - Comprehensive Cancer Centers of Nevada - Central Valley — Las Vegas, Nevada, United States
• John Theurer Cancer Center — Hackensack, New Jersey, United States
• University of Rochester — Rochester, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Levine Cancer Center — Charlotte, North Carolina, United States
• Levine Cancer Institute - Concord — Concord, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Highlands Oncology Group — Springdale, Arkansas, United States

Full record on ClinicalTrials.gov

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