Multiple Myeloma Clinical Trial

A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma

Summary

The main aims of this study is to test for any side effects from modakafusp alfa in combination therapy and to determine the recommended dose of combination therapy with modakafusp. 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. Participants will be given modakafusp alfa through a vein.

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Full Description

The drug being tested in this study is called modakafusp alfa (TAK-573). The study will evaluate the safety, tolerability and determine the recommended dose of modakafusp alfa in combination with lenalidomide in participants with newly diagnosed multiple myeloma (NDMM), or in combination with pomalidomide, bortezomib, carfilzomib, or daratumumab in participants with relapsed/refractory multiple myeloma (RRMM).

The study consists of 3 Groups: Group 1: NDMM Maintenance Therapy, Group 2: RRMM Doublets, Group 3: RRMM Triplets.

The study will enroll approximately 18 participants in Group 1, 54 in Group 2, and 72 in Group 3. Participants will be assigned to one of the following treatment groups as given below:

Group 1 (NDMM Maintenance) Arm 1: Modakafusp alfa + Lenalidomide
Group 2 (RRMM Doublets) Arm 2: Modakafusp alfa + Pomalidomide
Group 2 (RRMM Doublets) Arm 3: Modakafusp alfa + Bortezomib
Group 2 (RRMM Doublets) Arm 4: Modakafusp alfa + Carfilzomib
Group 3 RRMM Triplets) Arm A: Modakafusp alfa + Pomalidomide + Bortezomib
Group 3 (RRMM Triplets) Arm B: Modakafusp alfa + Carfilzomib + Pomalidomide
Group 3 (RRMM Triplets) Arm C: Modakafusp alfa + Daratumumab + Carfilzomib
Group 3 (RRMM Triplets) Arm D: Modakafusp alfa + Daratumumab + Pomalidomide

The study will be conducted worldwide. The maximum treatment duration in this study for Group 1 is until disease progression or unacceptable toxicity, or up to 2 years for minimal/measurable residual disease (MRD) negative participants, whichever occurs first. The maximum treatment duration in this study for Group 2 and Group 3 is until disease progression or unacceptable toxicity, whichever occurs first. Overall time to participate in the study is approximately up to 5 years.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Group 1 (NDMM maintenance: modakafusp alfa/lenalidomide) only must have:

NDMM based on standard IMWG diagnostic criteria, have undergone standard of care (SOC) induction therapy including an ASCT, and have achieved a major clinical response.
A history of measurable disease documented at time of diagnosis (before induction and ASCT).
Undergone ASCT within the 12 months of the start of induction therapy and completed ASCT within 180 days before enrollment. Time to initiation of maintenance therapy: participants may start maintenance therapy as early as 60 days after transplant and up to 180 days after transplant. Consolidation cycles are allowed.
Post ASCT MRD positive (10^-5 threshold by local SOC methods or central assessment, if a prior local MRD assessment had not been performed).
No prior progression after initial therapy (at any time before starting maintenance). Participants whose induction therapy was changed due to suboptimal response or toxicity will be eligible if they do not meet criteria for progression. In addition, no more than 2 regimens will be allowed before ASCT, excluding dexamethasone alone.
No prior allogeneic hematopoietic stem cell transplant or solid organ transplant.
Recovered to Grade less than or equal to (<=) 1 autologous stem cell transplant (ASCT) -related toxicities from the reversible effects of ASCT (except for alopecia and amenorrhea).

Groups 2 and 3 (RRMM doublets and RRMM triplets) must have:

Measurable disease, defined as at least one of the following:

Serum M-protein >=0.5 g/dL (>=5 g/L) on serum protein electrophoresis (SPEP).
Urine M-protein >=200 mg/24 hours on urine protein electrophoresis (UPEP).
Serum free light chain (FLC) assay result with an involved FLC level >=10 mg/dL (>=100 mg/L), provided the serum FLC ratio is abnormal (per IMWG criteria).
A confirmed diagnosis of MM according to IMWG criteria with documented disease progression in need of additional therapy as determined by the investigator.
For Group 2 RRMM doublet arms only: Participants who have received at least 3 prior lines of antimyeloma therapy, including at least 1 proteasome inhibitor (PI), 1 immunomodulatory (IMiD) and 1 anti-CD38 monoclonal antibody (mAb) drug, or who are triple refractory to a PI, an IMiD, and an anti-CD38 mAb drug regardless of the number of prior line(s) of therapy.

d. For Group 3 RRMM triplet arms only: Participants who have received 1 to 3 prior lines of antimyeloma therapy including at least 1 PI and, 1 IMiD, and who are not refractory to the combination partners.

e) For anti-CD38 arms, forced expiratory volume in 1 second >=50% by pulmonary function testing.

f) For carfilzomib arms, baseline echocardiogram with left ventricular ejection fraction >=50%.

Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at screening
Has adequate organ function at screening as determined by the laboratory values required for enrollment: Absolute neutrophil count (ANC) >=1000 per cubic millimeter (/mm^3) (or >=1*10^9/L); Platelets >=75,000/mm^3 (>=75*10^9/L); Hemoglobin >=8.0 g/dL; estimated creatinine clearance >=30 mL/min (Cockcroft-Gault formula); Total serum bilirubin <=2.0*Upper limit of normal (ULN); an exception for participants with Gilbert's syndrome may be granted after discussion with the sponsor; Liver transaminases (alanine aminotransferase [ALT])/aspartate aminotransferase [AST]) <=3.0*ULN.
Has recovered from adverse reactions to prior myeloma treatment or procedures (example, chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Version 5.0 Grade <=1 or baseline treatment or have the toxicity established as sequela, except for sensory or motor neuropathy, which should have recovered to Grade <=2 or baseline; Grade 1 for bortezomib arm.

Exclusion criteria:

Currently participating in another MM interventional study, including other clinical trials with investigational agents (including investigational vaccines or investigational medical device for disease under study) throughout the duration of this study.
Received previous treatment with modakafusp alfa.
Has a diagnosis of primary amyloidosis, Waldenström disease, monoclonal gammopathy of undetermined significance or smoldering MM per IMWG criteria or standard diagnostic criteria, plasma cell leukemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), lymphoplasmacytic lymphoma.
Has had another 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 and that in the opinion of the local investigator, with concurrence with the principal investigator, is considered cured with minimal risk of recurrence within 3 years.
Has evidence of CNS involvement and/or meningeal involvement due to MM exhibited during screening.
Has a known severe allergic or anaphylactic reactions to human recombinant proteins or excipients used in the modakafusp alfa formulation or to the study combination agents, the study medications, their analogs, or excipients in the various formulations of any agent per the prescribing information.
Is 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 and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) and, a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR.
Has a known history of seropositivity for HIV.
Is seropositive for hepatitis C (anti-hepatitis C virus antibody positive or anti-hepatitis C virus-RNA quantitation positive). Exception: Participants with a sustained virologic response with undetectable HCV RNA level at least 12 weeks after completion of antiviral therapy.
For bortezomib arms: participants received a strong cytochromes P450 (CYP3A4) inducer within 5 half-lives prior to randomization.
The participant has a chronic condition requiring the use of systemic corticosteroids >10 mg/dL of prednisone or equivalent, in addition to any required corticosteroids for the treatment of MM.
Has QT interval corrected with Fridericia correction method (QTcF) >480 millisecond (ms) (Grade >=2).

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

144

Study ID:

NCT05556616

Recruitment Status:

Recruiting

Sponsor:

Takeda

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There are 38 Locations for this study

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University of Arkansas for Medical Sciences (UAMS) - Winthrop P. Rockefeller Cancer Institute (Arkansas Cancer Research Center)
Little Rock Arkansas, 72205, United States More Info
Site Contact
Contact
501-526-2873
[email protected]
Frits van Rhee
Principal Investigator
Scripps Health
San Diego California, 92121, United States More Info
Site Contact
Contact
415-476-9000
[email protected]
Anuj Mahindra
Principal Investigator
University Of Colorado At Denver and Health Science Center
Aurora Colorado, 80045, United States More Info
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Contact
[email protected]
Peter Forsberg
Principal Investigator
Miami Cancer Institute at Baptist Health, Inc.
Miami Florida, 33176, United States More Info
Site Contact
Contact
786-527-8116
[email protected]
Guenther Koehne
Principal Investigator
The University of Iowa Hospitals & Clinics
Iowa City Iowa, 52242, United States More Info
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Contact
[email protected]
Christopher Strouse
Principal Investigator
Cancer Center of Kansas
Wichita Kansas, 67214, United States More Info
Site Contact
Contact
316-262-4467
[email protected]
Shaker Dakhil
Principal Investigator
Cancer Center At Greater Baltimore Medical Center
Baltimore Maryland, 21153, United States More Info
Site Contact
Contact
443-849-3051
[email protected]
Zhuoyan Li
Principal Investigator
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Site Contact
Contact
617-632-6140
[email protected]
Omar Nadeem
Principal Investigator
Karmanos Cancer Institute
Detroit Michigan, 48201, United States More Info
Site Contact
Contact
313-576-8673
[email protected]
Jeffrey Zonder
Principal Investigator
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89119, United States More Info
Site Contact
Contact
702-952-3400
[email protected]
Edwin Kingsley
Principal Investigator
New York University School of Medicine
New York New York, 10016, United States More Info
Site Contact
Contact
929-455-2451
[email protected]
Faith Davies
Principal Investigator
Weill Cornell Medicine/New York Presbyterian Hospital
New York New York, 10021, United States More Info
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Contact
[email protected]
Ruben Niesvizky
Principal Investigator
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States More Info
Site Contact
Contact
212-241-6756
[email protected]
Larysa Sanchez
Principal Investigator
Memorial Sloan Kettering Cancer Center - Main Campus
New York New York, 10065, United States More Info
Site Contact
Contact
646-608-3778
[email protected]
Carlyn Tan
Principal Investigator
Novant Health Cancer Institute
Charlotte North Carolina, 28204, United States More Info
Site Contact
Contact
[email protected]
Raymond Thertulien
Principal Investigator
Gabrail Cancer Center Research
Canton Ohio, 44718, United States More Info
Site Contact
Contact
330-492-3345
[email protected]
Nashat Gabrail
Principal Investigator
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States More Info
Site Contact
Contact
[email protected]
Asya Nina Varshavsky-Yanovsky
Principal Investigator
Vanderbilt University Medical Center (VUMC)
Nashville Tennessee, 37232, United States More Info
Site Contact
Contact
615-936-8422
[email protected]
Muhamed Baljevic
Principal Investigator
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Site Contact
Contact
713-792-3510
[email protected]
Hans Lee
Principal Investigator
Ordensklinikum Linz GmbH Elisabethinen
Linz , 5020, Austria More Info
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Contact
[email protected]
Irene Stassl
Principal Investigator
Uniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU
Salzburg , 5020, Austria More Info
Site Contact
Contact
435725525823
[email protected]
Richard Greil
Principal Investigator
CHU UCL Namur site Godinne
Yvoir Namur, 5530, Belgium More Info
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Contact
+3281422111
[email protected]
Julien Depaus
Principal Investigator
AZ Delta
Roeselare Roeselare West-Vlaanderen, 8800, Belgium More Info
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Contact
[email protected]
Dries Deeren
Principal Investigator
Centre Hospitalier Universitaire Sart Tilman
Liege , 4000, Belgium More Info
Site Contact
Contact
+32 43667704
[email protected]
Jo Caers
Principal Investigator
University Health Network (UHN) - Princess Margaret Cancer Centre - Myeloma Clinic
Toronto Ontario, M5G 2, Canada More Info
Site Contact
Contact
4169464501
[email protected]
Suzanne Trudel
Principal Investigator
McGill University Health Centre (MUHC) - The Montreal General Hospital (MGH) - Cedars Cancer Centre
Montreal Quebec, H4A 3, Canada More Info
Site Contact
Contact
93419345718
[email protected]
Anna Nikonova
Principal Investigator
Soroka University Medical Center (Sumc)
Be'er Sheva Beer Sheva Negev, 84101, Israel More Info
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Contact
[email protected]
Ory Rouvio
Principal Investigator
Assuta Ashdod Medical Center
Ashdod , 77476, Israel More Info
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Contact
[email protected]
Merav Leiba
Principal Investigator
Rabin Medical Center, Beilinson Campus
Petah Tikva , 49100, Israel More Info
Site Contact
Contact
[email protected]org.il
Julia Vaxman
Principal Investigator
IRCCS-Istituto Europeo di Oncologia, Division di Oncoematologia
Milan , 20141, Italy More Info
Site Contact
Contact
[email protected]
Enrico Derenzini
Principal Investigator
Azienda Ospedaliera Niguarda Ca' Granda
Milan , 20162, Italy More Info
Site Contact
Contact
+39 264442668
[email protected]
Anna Maria Cafro
Principal Investigator
Regina Elena National Cancer Institute
Rome , 144, Italy More Info
Site Contact
Contact
652665685
[email protected]
Andrea Mengarelli
Principal Investigator
Universita Cattolica del Sacro Cuore - Policlinico Universitario Agostino Gemelli, UOC Ematologia
Rome , 168, Italy More Info
Site Contact
Contact
630154968
[email protected]
Valerio De Stefano
Principal Investigator
Catalan Institute of Oncology (ICO) Hospitalet
Barcelona Catalunya, 8907, Spain More Info
Site Contact
Contact
935565649
[email protected]
Anna Sureda Balari
Principal Investigator
Hospital Universitario de Canarias
Santa Cruz de Tenerife Tenerife, 38320, Spain More Info
Site Contact
Contact
922-678-000
[email protected]
Sunil Lakhwani Lakhwani
Principal Investigator
Hospital Universitario La Fe de Valencia
Valencia Valecia, 46026, Spain More Info
Site Contact
Contact
661028232
[email protected]
Francisco Javier De La Rubia Comos
Principal Investigator
Hospital Universitario Virgen de la Victoria
Malaga , 29010, Spain More Info
Site Contact
Contact
951032468
[email protected]
Ricarda Garcia Sanchez
Principal Investigator
Clinica Universidad de Navarra, Dept of Oncology
Pamplona , 31008, Spain More Info
Site Contact
Contact
948-255-400
[email protected]
Paula Rodriguez Otero
Principal Investigator
Hammersmith Hospital - Imperial College Healthcare NHS Trust
London , W12 0, United Kingdom More Info
Site Contact
Contact
7913672624
[email protected]
Aristeidis Chaidos
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

144

Study ID:

NCT05556616

Recruitment Status:

Recruiting

Sponsor:


Takeda

How clear is this clinincal trial information?

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