BT062 in Combination With Lenalidomide or Pomalidomide and Dexamethasone in Patients With Multiple Myeloma

NCT01638936 | Completed Phase 1 DMC

• 1 other identifier: 983
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to test safety and anti-tumor activity of BT062 in combination with lenalidomide and dexamethasone to define the best doses for treating patients with relapsed and refractory multiple myeloma.

Conditions

Multiple Myeloma

Keywords

Combination; Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Determination of optimal dose of BT062 (Phase I part)

  The Phase I part will follow a standard dose escalation design with at least 3 patients per dose level to define optimal dose of BT062 in combination with lenalidomide/dexamethasone. Optimal dose will be defined by dose limiting toxicities (DLT) observed during Cycle 1 (28 days).

  6 months

• Evaluation of response (Phase IIa part)

  Response to treatment with optimal dose of BT062 (defined in Phase I part) in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone will be evaluated at baseline and at start of each Cycle (every 28 days). Response evaluation will be primarily based on assessment of M-protein and serum free light chains. If clinically required bone marrow analysis, plasmacytoma evaluation, and skeletal survey will be performed.

  18 months

Secondary Outcomes (4)

• Qualitative toxicities of BT062 in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone

  24 months

• Pharmacokinetics of BT062 in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone

  24 months

• Assessment of Time To Event end points

  24 months

• Quantitative toxicities of BT062 in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone

  24 months

Study Arms (1)

BT062

EXPERIMENTAL

BT062 administered intravenously on days 1, 8 and 15 of each 28-day cycle, and lenalidomide or pomalidomide and dexamethasone administered orally to subjects with relapsed or relapsed/refractory MM

Drug: BT062 , intravenous administration

Interventions

BT062 , intravenous administration DRUG

Dose escalation to determine dose limiting toxicities (DLTs) and/or the maximum tolerated dose (MTD)/recommended Phase II dose (RPTD) of BT062 in combination with lenalidomide/dexamethasone

Also known as: Indatuximab Ravtansine

BT062

Eligibility Criteria

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

You may qualify if:

• Diagnosis of active Multiple Myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
• Relapsed or relapsed/refractory progressive Multiple Myeloma
• Subjects who failed at least one prior therapy (BT062/Len/dex)
• Subjects who failed at least two prior therapy (BT062/Pom/dex)
• Subjects age ≥18 years
• Life expectancy of ≥12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status (Zubrod) ≤2
• Normal organ and bone marrow
• Signed written informed consent in accordance with federal, local, and institutional guidelines
• Subjects must agree to follow all Guidelines from REVLIMID REMS Program or POMALYST REMS
• Women of child bearing potential (WCBP), must agree to use 2 contraceptive methods

You may not qualify if:

• Chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to day 1 or those who have not recovered from adverse events (AEs) due to agents administered more than 3 weeks earlier
• Antineoplastic therapy with biological agents within 2 weeks before day 1 or within 5 drug half-lives (t½) prior to first dose, whichever time period is longer
• Concomitant antineoplastic therapies including chemotherapy, radiotherapy, or biological agents during the study
• Treatment with another investigational drug during the study or within 3 weeks before day 1 or within 5 drug half-live (t½) prior to first dose, whichever time period is longer
• Treatment with BT062 in previous studies
• Major surgery within 4 weeks before day 1 (this does not include placement of vascular access device or tumor biopsies)
• Malignancy within 3 years before day 1, other than the trial indication multiple myeloma and excluding treated non-melanoma skin cancer, superficial bladder cancer, carcinoma in-situ of the cervix and prostate carcinoma ≤ Gleason Grade 6 with stable prostate specific antigen (PSA) levels
• Subjects with plasma cell leukemia (PCL)
• Subjects with deep vein thrombosis (DVT) and Pulmonary embolism (PE) within 3 months prior to day 1 treatment
• Severe infections necessitating use of antibiotics / antivirals during the screening period
• Clinically relevant active infection including active hepatitis B or C or human immunodeficiency virus (HBV, HCV, or HIV) or any other concurrent disease
• Acute or relevant abnormalities in electrocardiogram (ECG)
• Significant cardiac disease
• Pregnant or breast-feeding
• Positive serum or urine pregnancy test

Sponsors & Collaborators

• Biotest Pharmaceuticals Corporation: lead
• Biotest: collaborator

Study Sites (10)

City of Hope

Duarte, California, 91010, United States

Location

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Memorial Healthcare System

Pembroke Pines, Florida, 33028, United States

Location

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Kelly KR, Ailawadhi S, Siegel DS, Heffner LT, Somlo G, Jagannath S, Zimmerman TM, Munshi NC, Madan S, Chanan-Khan A, Lonial S, Chandwani S, Minasyan A, Ruehle M, Barmaki-Rad F, Abdolzade-Bavil A, Rharbaoui F, Herrmann-Keiner E, Haeder T, Wartenberg-Demand A, Anderson KC. Indatuximab ravtansine plus dexamethasone with lenalidomide or pomalidomide in relapsed or refractory multiple myeloma: a multicentre, phase 1/2a study. Lancet Haematol. 2021 Nov;8(11):e794-e807. doi: 10.1016/S2352-3026(21)00208-8. Epub 2021 Sep 13.

  PMID: 34529955 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Administration, Intravenous; indatuximab ravtansine

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)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Kenneth C Anderson, MD

  Dana-Farber Cancer Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: July 12, 2012
• Study Start: July 3, 2012
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

US (10)