Study to Separately Evaluate the Activity of Talacotuzumab (JNJ-56022473) or Daratumumab in Transfusion-Dependent Participants With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Who Are Relapsed or Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

NCT03011034 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: CR1082612016-003328-2256022473MDS2002
• Study Type: interventional
• Target: 34
• Locations: 6 countries
• Sites: 21

Brief Summary

The main purpose of the study is to evaluate the efficacy (transfusion independence \[TI\]) of talacotuzumab (JNJ-56022473) or daratumumab in transfusion-dependent participants with low or intermediate-1 risk Myelodysplastic Syndrome (MDS) whose disease has relapsed during treatment with or is refractory to Erythropoiesis-Stimulating Agent (ESAs).

Conditions

Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence (TI) Lasting at Least 8 Weeks

  Percentage of participants who achieved RBC TI lasting at least 8 weeks were reported. RBC TI was defined as absence of RBC transfusion during any consecutive 56 days (8 weeks) post randomization.

  Up to 2 years

Secondary Outcomes (11)

• Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence (TI) Lasting at Least 24 Weeks

  Up to 2 years

• Time to Transfusion Independence (TI)

  Up to 2 years

• Duration of Transfusion Independence (TI)

  Up to 2 years

• Percentage of Participants Who Met IWG Criteria for Transfusion Reduction

  Up to 2 years

• Percentage of Participants With at Least One Dose of Myeloid Growth Factors Usage

  Up to 2 years

Study Arms (2)

Talacotuzumab

EXPERIMENTAL

Participants will receive talacotuzumab 9 milligram per kilogram (mg/kg) intravenously (IV) on Days 1 and 15 for all cycles. Each treatment cycle is of 28 days. The talacotuzumab arm of the study is closed for enrollment.

Drug: Talacotuzumab

Daratumumab

EXPERIMENTAL

Participants will receive daratumumab 16 mg/kg IV on Days 1, 8, 15, and 22 for Cycles 1 and 2; on Days 1 and 15 for Cycles 3 to 6; and on Day 1 for all subsequent cycles. Each treatment cycle is of 28 days.

Drug: Daratumumab

Interventions

Talacotuzumab DRUG

Talacotuzumab 9 mg/kg will be administered as an IV infusion.

Also known as: JNJ-56022473

Talacotuzumab

Daratumumab DRUG

Daratumumab 16 mg/kg will be administered as an IV infusion.

Also known as: JNJ-54767414

Daratumumab

Eligibility Criteria

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

You may qualify if:

• Myelodysplastic Syndrome (MDS) according to World Health Organization (WHO) criteria confirmed by bone marrow aspirate and biopsy within 12 weeks prior to first dose. A local laboratory report from this diagnostic bone marrow aspirate and biopsy must be approved by the sponsor
• International Prognostic Scoring System (IPSS) low risk or intermediate-1 risk MDS
• Red blood cell (RBC) transfusion dependent, 1) Received at least 4 units of RBCs over any 8 consecutive weeks during the 16 weeks prior to randomization, 2) Pretransfusion Hb must have been less than or equal to (\<=)9.0 gram per deciliter (g/dL)
• Adequate iron stores, defined as transferrin saturation greater than 20 percent (%) and serum ferritin greater than 400 nanogram per Milliliter (ng/mL), measured within the screening period, or adequate iron stores as demonstrated by recent (within 12 weeks prior to first dose) bone marrow examination with iron stain
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

You may not qualify if:

• Known allergies, hypersensitivity, or intolerance to talacotuzumab and daratumumab or their excipients
• Received any chemotherapy, immunomodulatory or immunosuppressive therapy, corticosteroids (greater than \[\>\]30 milligram per day \[mg/day\] prednisone or equivalent) within 28 days prior to randomization
• Received other treatments for MDS within 28 days prior to first dose (example \[eg\], azacitidine, decitabine, lenalidomide, Erythropoiesis-Stimulating Agent (ESA) (8 weeks for long-acting ESAs)
• History of hematopoietic stem cell transplant
• Del(5q) karyotype unless treatment with lenalidomide has failed. Failure is defined as either: 1) having received at least 3 months of lenalidomide treatment without RBC transfusion benefit (International Working Group \[IWG\] 2006); 2) progression or relapse after hematologic improvement with lenalidomide (IWG 2006); 3) discontinuation of lenalidomide due to toxicity; or 4) unable to receive lenalidomide due to a contraindication. Source documentation for lenalidomide treatment failure must be verified by the sponsor

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (21)

Washington University School Of Medicine

St Louis, Missouri, 63110, United States

Location

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

ZNA Stuivenberg

Antwerp, 2060, Belgium

Location

Az Groeninge

Kortrijk, 8500, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

AZ Turnhout

Turnhout, 2300, Belgium

Location

Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna

Bologna, 40138, Italy

Location

Azienda Ospedaliero Universitaria Careggi

Florence, 50134, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Pad. Marcora

Milan, 20122, Italy

Location

Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

UMCG

Groningen, 9713 GZ, Netherlands

Location

Erasmus MC

Rotterdam, 3075 EA, Netherlands

Location

Haga ziekenhuis

The Hague, 2545 CH, Netherlands

Location

City Clinical Hospital # 40

Moscow, 129301, Russia

Location

Nizhniy Novgorod Region Clinical Hospital

Nizhny Novgorod, 603126, Russia

Location

Saint Petersburg City Hospital #15

Saint Petersburg, 123182, Russia

Location

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

Location

Hosp. Univ. de La Princesa

Madrid, 28006, Spain

Location

Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain

Location

Hosp. Univ. I Politecni La Fe

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

daratumumab

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Limitations and Caveats

Study objectives were not pursued in talacotuzumab arm; enrollment in this arm was stopped due to a serious infusion-related reaction after first dose in first participant assigned to talacotuzumab.

Results Point of Contact

• Title: Global Medical Head
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 5, 2017
• Study Start: February 14, 2017
• Primary Completion: January 23, 2019
• Study Completion: October 5, 2021
• Last Updated: March 4, 2025
• Results First Posted: March 13, 2020

Record last verified: 2025-03

Locations

ES (4); BE (4); IT (4); NL (3); RU (3); US (3)