A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia

NCT03187262 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 17-164
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 5

Brief Summary

This research study is studying Daratumumab as a possible treatment for Waldenström Macroglobulinemia.

Conditions

Waldenström Macroglobulinemia

Keywords

Waldenström Macroglobulinemia

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Overall Response Rate= Minor response (\>25%-50% reduction in serum IgM from baseline) + Partial Response (\>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (\>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly).

  2 years

Secondary Outcomes (5)

• Progression Free Survival

  4 years

• Number of Participants With Complete Response

  2 years

• Number of Participants With Partial Response

  2 years

• Number of Participants With Very Good Partial Response

  2 years

• Number of Participants With Minor Response

  2 years

Study Arms (1)

Daratumumab

EXPERIMENTAL

* Daratumumab will be administered in three phases: Induction, consolidation and maintenance * During induction, participants will receive daratumumab on days 1, 8, 15 and 22 of each 28-day * During consolidation, daratumumab will be administered on days 1 and 15 of each 28-day cycle * During maintenance, daratumumab will be administered on day 1 of each 28-day cycle

Drug: Daratumumab

Interventions

Daratumumab DRUG

Daratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories

Also known as: Darzalex

Daratumumab

Eligibility Criteria

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

You may qualify if:

• Clinicopathological diagnosis of Waldenström Macroglobulinemia (Owen et al. 2003), and meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenström macroglobulinemia (Kyle et al. 2003)
• At least one previous treatment for WM with either documented disease progression or no response (stable disease) to the most recent treatment regimen
• Measurable disease, defined as presence of serum immunoglobulin M (IgM) with a minimum IgM level of \>2 times the upper limit of normal of each institution is required
• Participants with symptomatic hyperviscosity or serum IgM \>5,000 mg/dL to undergo plasmapheresis prior to treatment initiation
• Age ≥18 years
• ECOG performance status ≤2 (see Appendix A)
• Participants must have preserved organ and marrow function as defined below:
• Absolute neutrophil count ≥ 1,000/mcL
• Platelets ≥ 50,000/mcL
• Hemoglobin ≥ 8 g/dL
• Total bilirubin ≤ 1.5 mg/dL or \< 2 mg/dL if attributable to hepatic infiltration by neoplastic disease
• AST/ALT ≤ 2.5 × institutional upper limit of normal
• EGFR ≥ 30 ml/min
• Not on any active therapy for other malignancies with the exception of topical therapies for basal cell or squamous cell cancers of the skin.
• Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or have or will have complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) while participating in the study; and 2) for at least 90 days after discontinuation from the study. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. FCBP must be referred to a qualified provider of contraceptive methods if needed. FCBP must have a negative serum pregnancy test at screening.

You may not qualify if:

• Any serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent study participation.
• Concurrent use of any other anti-cancer agents or treatments or any other investigational agents.
• Any condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• Known CNS lymphoma.
• New York Heart Association classification III or IV heart failure.
• Known history of Human Immunodeficiency Virus (HIV), active infection with Hepatitis B Virus (HBV), and/or Hepatitis C Virus (HCV).
• Lactating or pregnant women.
• Grade \>2 toxicity (other than alopecia) continuing from prior anti-cancer therapy.
• History of non-compliance to medical regimens.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Janssen, LP: collaborator

Study Sites (5)

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Interventions

daratumumab

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; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Dr. Jorge Castillo
• Organization: Dana-Farber Cancer Institute

jorgej_castillo@dfci.harvard.edu

617-632-2681

Study Officials

• Jorge J Castillo, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 14, 2017
• Study Start: November 27, 2017
• Primary Completion: January 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 23, 2022
• Results First Posted: April 22, 2021

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)