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

NCT03215030 | Terminated Phase 1 Results DMC FDA Drug

• 5 other identifiers: TAK-573-1501TV48573-ONC-10128U1111-1195-81342021-006038-37jRCT2061220078
• Study Type: interventional
• Target: 272
• Locations: 16 countries
• Sites: 94

Brief 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.

Conditions

Multiple Myeloma

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (12)

• Part 1: Percentage of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs)

  An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.

  Up to 54.3 months in Part 1

• Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)

  DLTs were evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Nonhematologic TEAEs of NCI CTCAE Grade ≥3 clearly unrelated to the underlying disease and occurring during the first cycle were considered DLTs.

  Up to Cycle 1 (cycle length was 28 days for Schedule A, B and D; 21 days for Schedule C)

• Part 1: Percentage of Participants Reporting One or More Grade 3 or Higher TEAEs

  An AE is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. TEAEs grades were evaluated as per NCI CTCAE, Version 5.0. Grade 1 scaled as mild; Grade 2 scaled as moderate; Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE. Percentages were rounded off to the nearest decimal.

  Up to 54.3 months in Part 1

• Part 1: Percentage of Participants Reporting One or More Serious Treatment-emergent Adverse Events (Serious TEAEs)

  AE: any untoward medical occurrence in participants administered a pharmaceutical product; untoward medical occurrence does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal (investigational) product whether or not it is related to medicinal product. TEAE: any AE either reported for first time or worsening of pre-existing event after first dose of study drug \& within 30 days of last administration of study drug. Serious TEAEs: any untoward medical occurrence that: 1)results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is medically important event. Percentages were rounded off to nearest decimal.

  Up to approximately 54.3 months in Part 1

• Part 1: Percentage of Participants Who Discontinued the Treatment Because of TEAE

  An AE is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. Percentages were rounded off to the nearest decimal.

  Up to 54.3 months in Part 1

• Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Delay

  Percentages were rounded off to the nearest decimal.

  Up to 54.3 months in Part 1

• Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Interruptions

  Percentages were rounded off to the nearest decimal.

  Up to 54.3 months in Part 1

• Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Reductions

  Percentages were rounded off to the nearest decimal.

  Up to 54.3 months in Part 1

• Part 1: Percentage of Participants With Clinically Significant Laboratory Values

  Laboratory values included hematology, chemistry, and urinalysis and were assessed per investigator's interpretation.

  Up to 54.3 months in Part 1

• Part 1: Percentage of Participants With Clinically Significant Vital Signs Measurements

  Vital signs included temperature, pulse, respiratory rate, oxygen saturation, and blood pressure.

  Up to 54.3 months in Part 1

• Part 2: Overall Response Rate (ORR)

  ORR was defined as the percentage of participants who achieved a partial response (PR) rate or better (stringent complete response \[sCR\] + complete response \[CR\] + very good partial response \[VGPR\] + PR) during the study as defined by international myeloma working group (IMWG) uniform response criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. sCR: CR+normal free light chain (FLC) ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR:serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours.

  Up to 34.7 months in Part 2

• Part 3: Overall Response Rate (ORR) Assessed by Independent Review Committee (IRC)

  ORR was defined as the percentage of participants who achieved a PR rate or better (sCR + CR + VGPR + PR) during the study as defined by IMWG uniform response criteria. PR :≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 hours. CR:negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. Scr: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR:serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours.

  Up to 20.5 months in Part 3

Secondary Outcomes (41)

• Parts 1 and 2: Percentage of Participants With Dose-limiting Toxicities (DLTs)- Like Events

  Up to 54.3 months in Part 1; Up to 34.7 months in Part 2

• Part 1: Cmax: Maximum Observed Serum Concentration for Modakafusp Alfa

  Part 1:Schedule A:Day 1&15 in Cycles 1&2; Schedule B: Day1&15 in Cycles 1&2; Schedule C:Day1 in Cycles 1&2; Schedule D: Day 1 in Cycles 1&2: Pre-infusion&at multiple times post-infusion (cycle length was 28 days for Schedule A, B&D;21 days for Schedule C)

• Part 1: Tmax: Time to Reach the Cmax for Modakafusp Alfa

  Part 1:Schedule A:Day 1&15 in Cycles 1&2; Schedule B: Day1&15 in Cycles 1&2; Schedule C:Day1 in Cycles 1&2; Schedule D: Day 1 in Cycles 1&2: Pre-infusion&at multiple times post-infusion (cycle length was 28 days for Schedule A, B&D;21 days for Schedule C)

• Part 1: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa

  Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)

• Part 1: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp Alfa

  Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)

Study Arms (12)

Part 1 (Dose Escalation) Schedule A

EXPERIMENTAL

Participants received Modakafusp alfa 0.001 up to 0.75 milligram per kilogram (mg/kg), infusion, intravenously (IV), once every week (Q1W) on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once every 2 weeks (Q2W) on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once every 4 weeks (Q4W) on Day 1 of each 28-day treatment cycle until treatment discontinuation.

Drug: Modakafusp alfa

Part 1 (Dose Escalation) Schedule B

EXPERIMENTAL

Participants received Modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.

Drug: Modakafusp alfa

Part 1 (Dose Escalation) Schedule C

EXPERIMENTAL

Participants received Modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, once every 3 weeks (Q3W) on Day 1 of each 21-day treatment cycle until treatment discontinuation.

Drug: Modakafusp alfa

Part 1 (Dose Escalation) Schedule D

EXPERIMENTAL

Participants received Modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.

Drug: Modakafusp alfa

Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa

EXPERIMENTAL

Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.

Drug: Modakafusp alfa

Part 2 (Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone

EXPERIMENTAL

Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.

Drug: Modakafusp alfa; Drug: Dexamethasone

Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa

EXPERIMENTAL

Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.

Drug: Modakafusp alfa

Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone

EXPERIMENTAL

Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.

Drug: Modakafusp alfa; Drug: Dexamethasone

Part 3 (Dose Extension): Modakafusp Alfa 120 mg

EXPERIMENTAL

Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.

Drug: Modakafusp alfa

Part 3 (Dose Extension): Modakafusp Alfa 240 mg

EXPERIMENTAL

Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.

Drug: Modakafusp alfa

Japan Lead-in: Modakafusp Alfa 60 mg

EXPERIMENTAL

Participants received modakafusp alfa 60 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.

Drug: Modakafusp alfa

Japan Lead-in: Modakafusp Alfa 120 mg

EXPERIMENTAL

Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.

Drug: Modakafusp alfa

Interventions

Modakafusp alfa DRUG

Modakafusp alfa intravenous infusion.

Also known as: TAK-573, TEV-48573

Japan Lead-in: Modakafusp Alfa 120 mg; Japan Lead-in: Modakafusp Alfa 60 mg; Part 1 (Dose Escalation) Schedule A; Part 1 (Dose Escalation) Schedule B; Part 1 (Dose Escalation) Schedule C; Part 1 (Dose Escalation) Schedule D; Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa; Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa; Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone; Part 2 (Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone; Part 3 (Dose Extension): Modakafusp Alfa 120 mg; Part 3 (Dose Extension): Modakafusp Alfa 240 mg

Dexamethasone DRUG

Dexamethasone.

Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone; Part 2 (Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D LLC: lead

Study Sites (94)

Highlands Oncology Group

Springdale, Arkansas, 72762, United States

Location

Los Angeles Cancer Network - Glendale Adventist Medical Center

Glendale, California, 91204, United States

Location

University of California Irvine

Orange, California, 92868, United States

Location

Office of James R. Berenson MD

West Hollywood, California, 90069, United States

Location

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, 06520, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern Medicine - Northwestern Medical Group

Chicago, Illinois, 60611, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Investigative Clinical Research of Indiana, LLC

Noblesville, Indiana, 46062, United States

Location

June E. Nylen Cancer Center

Sioux City, Iowa, 51101, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Univeristy of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

USOR - Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, 89119, United States

Location

John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

Location

University of Rochester

Rochester, New York, 14627, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Levine Cancer Center

Charlotte, North Carolina, 28402, United States

Location

Levine Cancer Institute - Concord

Concord, North Carolina, 28205, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718-2566, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Baptist Cancer Center - Memphis - Walnut Grove

Memphis, Tennessee, 38120, United States

Location

Lumi Research

Houston, Texas, 77002, United States

Location

British Columbia Cancer Agency Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Centre de Recherche du CHUM

Montreal, Quebec, H2X 0C1, Canada

Location

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100089, China

Location

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

Wuhan Union Hospital

Wuhan, Hubei, 430023, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

The First Affiliated Hospital of Soochow University - Suzhou First People's Hospital

Suzhou, Jiangsu, 215006, China

Location

Shanghai Fourth People's Hospital

Shanghai, Shanghai Municipality, 200003, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Institut de cancerologie Strasbourg Europe

Strasbourg, Alsace, 67200, France

Location

Hopital Saint-Vincent de Paul - Lille

Lille, Hauts-de-France, 59020, France

Location

Centre Hospitalier Regional Universitaire de Lille

Lille, Hauts-de-France, 59037, France

Location

Centre Hospitalier Universitaire de Toulouse Hopital Purpan

Toulouse, Midi-pyrenees, 31059, France

Location

Centre Hospitalier Universitaire Nantes - Hotel Dieu

Nantes, Pays de la Loire Region, 44093, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, Poitou-charentes, 86000, France

Location

Centre Hospitalier d'Argenteuil - Centre Hospitalier Victor Dupouy

Argenteuil, 95107, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, Île-de-France Region, 91010, France

Location

Hopital Saint-Antoine

Paris, Île-de-France Region, 75012, France

Location

Hopital Necker-Enfants Malades

Paris, Île-de-France Region, 75015, France

Location

Universitatsklinik Tubingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Universitatsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

Location

Evaggelismos General Hospital

Athens, Attica, 10676, Greece

Location

Alexandra General Hospital of Athens

Athens, Attica, 11528, Greece

Location

University Regional General Hospital of Patras

Patra, Peloponnese, 26504, Greece

Location

The Chaim Sheba Medical Center

Ramat Gan, Tel Aviv, 52621, Israel

Location

Hadassah Medical Center

Jerusalem, 9112001, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

AON SS Antonio e Biagio e Cesare Arrigo

Alessandria, 15121, Italy

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

Ancona, 60126, Italy

Location

Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant'Orsola-Malpighi

Bologna, 40138, Italy

Location

Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

Catania, 95125, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8601, Japan

Location

Ogaki Municipal Hospital

Gifu, Gifu, 503-8502, Japan

Location

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Kyoto, 602-855, Japan

Location

National Hospital Organization Okayama Medical Center

Okayama, Okayama-ken, 701-1192, Japan

Location

Japanese Red Cross Medical Center

Tokyo, 150-8935, Japan

Location

Oslo Universitetssykehus-Ulleval Hospital

Oslo, 0450, Norway

Location

Ad-Vance Medical Research

Ponce, PR, 00730, Puerto Rico

Location

Hospital Espanol Auxilio Mutuo

San Juan, 00919, Puerto Rico

Location

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 58128, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

The Catholic University of Korea - Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Tri-Service General Hospital

Taipei, Taipei CITY, 11490, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Ankara Universitesi

Yenimahalle, Ankara, 06560, Turkey (Türkiye)

Location

Ondokuz Mayis Universitesi Tp Fakultesi

Samsun, 55139, Turkey (Türkiye)

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, England, B9 5SS, United Kingdom

Location

Royal Cornwall Hospital NHS Trust

Cornwell, England, TR1 3LI, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, England, NW1 2BU, United Kingdom

Location

Genesis Care - Milton Keynes

Milton Keynes, England, MK14 6LS, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, England, OX3 7LE, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

Sutton, England, SM2 5PT, United Kingdom

Location

Genesis Care Windsor - Genesis Care UK Ltd.

Windsor, England, SL43HD, United Kingdom

Location

Related Publications (2)

• Holstein SA, Atrash S, Mian H, Dimopoulos MA, Schjesvold F, Popat R, Shah N, Gatt ME, Gocke CB, Frenzel L, Touzeau C, Beksac M, Manier S, Magen H, Travis P, Nadeem O, Suryanarayan K, Li C, Li S, Nelson A, Cherepanov D, Parot X, Vogl DT. A phase 2 randomized study of modakafusp alfa as a single agent for patients with relapsed/refractory multiple myeloma. Blood. 2025 Aug 28;146(9):1051-1064. doi: 10.1182/blood.2024027873.

  PMID: 40279508 DERIVED

• Vogl DT, Atrash S, Holstein SA, Nadeem O, Benson D, Chaudry M, Biran N, Suryanarayan K, Li C, Liu Y, Collins S, Parot X, Kaufman JL. Targeted interferon therapy with modakafusp alfa for relapsed or refractory multiple myeloma. Blood. 2025 Feb 27;145(9):944-955. doi: 10.1182/blood.2024026124.

  PMID: 39630057 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

The study was terminated early due to discontinuation of development of modakafusp alfa for strategic reasons. The November 7 2024 data cut comprises the final full dataset for safety and efficacy.

Results Point of Contact

• Title: Study Director
• Organization: Teva Branded Pharmaceutical Products R&D LLC

USMedInfo@tevapharm.com

1-888-483-8279

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 12, 2017
• Study Start: October 4, 2017
• Primary Completion: July 1, 2024
• Study Completion: November 7, 2024
• Last Updated: January 29, 2026
• Results First Posted: October 20, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

TW (2); IT (5); JP (5); NO (1); GB (7); FR (10); CA (4); ES (7); CN (11); TU (2); US (27); GR (3); DE (2); IL (3); PR (2); KR (3)