BB-10901 in Treating Patients With Relapsed and/or Refractory Multiple Myeloma

NCT00346255 | Completed Phase 1

• 3 other identifiers: CDR0000491241IMMUNO-003DFCI-05031
• Study Type: interventional
• Target: 37
• Locations: 2 countries
• Sites: 8

Brief Summary

RATIONALE: Monoclonal antibodies, such as BB-10901, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. PURPOSE: This phase I trial is studying the side effects and best dose of BB-10901 in treating patients with relapsed and/or refractory multiple myeloma.

Conditions

Multiple Myeloma

Keywords

stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity

  through cycle 1

• Maximum tolerated dose

  for the duration of the study

Secondary Outcomes (3)

• Qualitative and quantitative toxicities

  for the duration of the study

• Pharmacokinetics

  for the duration of the study

• Anti-tumor activity including overall response rate, time to progression and survival

  for the duration of the study

Interventions

BB-10901 DRUG

dose escalation study, doses will vary per cohort. patients will receive an IV infusion weekly for two weeks every three weeks.

Also known as: IMGN901

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed multiple myeloma * Relapsed or relapsed/refractory disease * Failed ≥ 1 prior therapy for multiple myeloma * Once the MTD is defined, only patients who have received at least 1 but equal or less than 6 prior chemotherapy regimens will be enrolled at this dose level * CD56-positive disease confirmed by immunohistochemistry or flow cytometry PATIENT CHARACTERISTICS: * ECOG (Zubrod) performance status 0-2 * Life expectancy ≥ 12 weeks * Platelet count ≥ 75,000/mm\^3 * Absolute neutrophil count \> 1,000/mm\^3 * Hemoglobin ≥ 8.5 g/dL * AST and ALT ≤ 3 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * Amylase and lipase within normal limits * Creatinine ≤ 2 mg/dL * Left ventricular ejection fraction ≥ lower limit of normal on MUGA or ECHO * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No peripheral neuropathy ≥ grade 3 or painful grade 2 neuropathy * No significant cardiac disease, including any of the following: * Myocardial infarction within the past 6 months * Unstable angina * Uncontrolled congestive heart failure * Uncontrolled hypertension (i.e., recurrent or persistent increases in systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 110 mm Hg) * Uncontrolled cardiac arrhythmias * Cardiac toxicity ≥ grade 3 after prior chemotherapy * No history of multiple sclerosis or other demyelinating disease * No hemorrhagic or ischemic stroke within the past 6 months * No Eaton-Lambert syndrome (para-neoplastic syndrome) * No CNS injury with residual neurological deficit (other than peripheral neuropathy ≤ grade 2) * No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ prostate cancer * No clinically relevant active infection, including active hepatitis B or C infection or HIV infection * No other condition or disease, including laboratory abnormalities, that, in the opinion of the investigator, may preclude study treatment * No known recent biochemical or clinical evidence of pancreatitis or extensive metastatic disease involving the pancreas PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) * At least 4 weeks since prior radiotherapy * At least 4 weeks since prior major surgery (except placement of a vascular access device or tumor biopsies) * More than 4 weeks since prior investigational agents * At least 2 weeks since prior antineoplastic therapy with biological agents * No prior hypersensitivity to monoclonal antibody therapy * No other concurrent investigational agents * No concurrent corticosteroids (except as indicated for other medical conditions \[\< 10 mg prednisone or equivalent\]; as pre-medication for administration of certain medications or blood products \[≤ 100 mg hydrocortisone\]; or for treatment of infusion reactions) * Concurrent topical steroids allowed * No other concurrent antineoplastic treatment (e.g., chemotherapy, radiotherapy, or biological agents) * Concurrent bisphosphonates allowed provided patient began bisphosphonates before study entry and is maintained on a stable dose during study treatment

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• ImmunoGen, Inc.: lead

Study Sites (8)

Cedars-Sinai Outpatient Cancer Center

Los Angeles, California, United States

Location

UCSF

San Francisco, California, 94143, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

St. Vincent's Comprehensive Cancer Center - Manhattan

New York, New York, 10011, United States

Location

Juan Domingo Peron 1500 - (B1629AHJ) Pilar

Buenos Aires, Buenos Aires, Argentina

Location

Gascon 450 - (C1181ACH)

Buenos Aires, Buenos Aires F.D., Argentina

Location

Av. Naciones Unidas 346. (X5016KEH)-Barrio Parque Velez Sarfield

Córdoba, Córdoba Province, Argentina

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

lorvotuzumab mertansine

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

Study Officials

• Asher Alban Akmal Chanan-Khan,, M.D.

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 28, 2006
• First Posted: June 29, 2006
• Study Start: April 1, 2005
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 23, 2013

Record last verified: 2013-04

Locations

AR (3); US (5)