Multiple Myeloma Clinical Trial
A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma
Summary
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.
Full Description
The drug being tested in this study, and which will be given through a vein, is called modakafusp alfa (TAK-573 ) as single agent or in combination with dexamethasone. The study will determine the safety, tolerability, and efficacy of modakafusp alfa as single agent and in combination with dexamethasone in participants with relapsed/refractory multiple myeloma (RRMM). The study consists of 3 Parts:
Part 1: Dose Escalation, Part 2: Dose Expansion, Part 3: Dose Extension
The study will enroll approximately 65 participants in Part 1, 35 in Part 2, and 236 in Part 3. Participants will be assigned to one of the following treatment groups in Parts 1 and 2 of the study. Participants will be randomly assigned in Part 3 of the study as given below:
Part 1 (Dose Escalation) Schedule A: Modakafusp alfa 0.001 Up to 14 mg/kg
Part 1 (Dose Escalation) Schedule B: Modakafusp alfa TBD
Part 1 (Dose Escalation) Schedule C: Modakafusp alfa TBD
Eligibility Criteria
Inclusion Criteria:
For Parts 1 and 2:
1. 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.
Exclusion Criteria:
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.
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There are 94 Locations for this study
Springdale Arkansas, 72762, United States
Glendale California, 91204, United States
Orange California, 92868, United States
West Hollywood California, 90069, United States
New Haven Connecticut, 06520, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60611, United States
Maywood Illinois, 60153, United States
Noblesville Indiana, 46062, United States
Sioux City Iowa, 51101, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02118, United States
Boston Massachusetts, 02215, United States More Info
Principal Investigator
Omaha Nebraska, 68198, United States More Info
Principal Investigator
Las Vegas Nevada, 89119, United States
Hackensack New Jersey, 07601, United States
Bronx New York, 10467, United States
Rochester New York, 14627, United States
Charlotte North Carolina, 28402, United States More Info
Principal Investigator
Concord North Carolina, 28205, United States
Durham North Carolina, 27710, United States
Canton Ohio, 44718, United States
Columbus Ohio, 43210, United States More Info
Principal Investigator
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, 19104, United States More Info
Principal Investigator
Memphis Tennessee, 38120, United States
Houston Texas, 77002, United States
Vancouver British Columbia, V5Z 4, Canada
Hamilton Ontario, L8V 5, Canada
Montreal Quebec, H2X 0, Canada
Montreal Quebec, H3T 1, Canada
Beijing Beijing, 10004, China
Beijing Beijing, 10008, China
Guangzhou Guangdong, 51006, China
Zhengzhou Henan, 45000, China
Wuhan Hubei, 43002, China
Wuhan Hubei, 43007, China
Nanjing Jiangsu, 21000, China
Suzhou Jiangsu, 21500, China
Shanghai Shanghai, 20000, China
Tianjin Tianjin, 30006, China
Hangzhou Zhejiang, 31000, China
Strasbourg Alsace, 67200, France
Creteil Cedex Ile-de-france, 91010, France
Paris Cedex 12 Ile-de-france, 75012, France
Paris Ile-de-france, 75015, France
Toulouse Midi-pyrenees, 31059, France
Lille Cedex NORD Pas-de-calais, 59020, France
Lille Cedex NORD Pas-de-calais, 59037, France
Nantes Cedex 1 PAYS DE LA Loire, 44093, France
Poitiers Poitou-charentes, 86000, France
Argenteuil Cedex , 95107, France
Tuebingen Baden-wuerttemberg, 72076, Germany
Leipzig Sachsen, 04103, Germany
Athens Attica, 10676, Greece
Athens Attica, 11528, Greece
Patra Peloponnese, 26504, Greece
Ramat Gan Tel Aviv, 52621, Israel
Jerusalem , 91120, Israel
Tel Aviv , 64239, Israel
Alessandria , 15121, Italy
Ancona , 60126, Italy
Bologna , 40138, Italy
Catania , 95125, Italy
Pavia , 27100, Italy
Nagoya Aichi, 467-8, Japan More Info
Principal Investigator
Gifu-shi Gifu, 503-8, Japan More Info
Principal Investigator
Kyoto-City Kyoto, 602-8, Japan More Info
Principal Investigator
Okayama-city Okayama, 701-1, Japan More Info
Principal Investigator
Tokyo , 150-8, Japan More Info
Principal Investigator
Hwasun Jeollanam-do, 58128, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 06591, Korea, Republic of
Oslo , 0450, Norway
Ponce , 00730, Puerto Rico
San Juan , 00919, Puerto Rico
Badalona Barcelona, 08916, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28041, Spain
Murcia , 30120, Spain
Salamanca , 37007, Spain
Santander , 39008, Spain
Taipei Taipei CITY, 11490, Taiwan
Taipei , 100, Taiwan
Yenimahalle Ankara, 06560, Turkey
Samsun , 55139, Turkey
Birmingham England, B9 5S, United Kingdom
Cornwell England, TR1 3, United Kingdom
London England, NW1 2, United Kingdom
Milton Keynes England, MK14 , United Kingdom
Oxford England, OX3 7, United Kingdom
Sutton England, SM2 5, United Kingdom
Windsor England, SL43H, United Kingdom
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