PTK/ZK as Post Transplant Maintenance Therapy in Patients With Multiple Myeloma

NCT00240162 | Terminated Phase 2 Results

• 2 other identifiers: 05-0639IND#: 72,721
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study it to evaluate the efficacy of PTK787/ZK 222584, in inducing at least a 50% reduction in paraprotein in patients with multiple myeloma whose paraprotein levels are \< 5 g/dL following high dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT).

Conditions

Multiple Myeloma

Keywords

Myeloma; PTK

Outcome Measures

Primary Outcomes (1)

• Detectable Paraprotein Level (IgG or IgA)at ≤5 g/dL Who Show a 50% Reduction (Complete Response + Partial Response) in Their Paraprotein After Starting Treatment With the Study Drug

  Day 90

Secondary Outcomes (3)

• Time to Progression

  Until the patient progresses or expires (up to 457 days)

• Safety and Tolerability of PTK787/ZK 222584

  30 days after treatment ends [median of 15 cycles (11-32)]

• Disease Free Survival

  Until the patient expires

Study Arms (1)

PTK787/ZK 222584

EXPERIMENTAL

Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.

Drug: PTK787/ZK 222584

Interventions

PTK787/ZK 222584 DRUG

Also known as: N/Bemzoylstaurosporine

PTK787/ZK 222584

Eligibility Criteria

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

You may qualify if:

• Patients eligible for this trial are those diagnosed with multiple myeloma by standard criteria and treated with HDCT and ASCT on protocols at Washington University School of Medicine. Following HDCT and ASCT patients must have:
• M-component (IgG or IgA) with persistent measurable paraprotein, or \>=2 g monoclonal protein in 24 hr urine specimen or patients with an abnormal serum kappa/lambda ratio and a level of kappa or lambda light chain \> 10 mg/dl.
• \>=90 days and \<= 120 days post transplant
• Laboratory values less than or equal to 2 weeks prior to initiation of treatment:
• Absolute neutrophil count (ANC) greater than or equal 1.5 x 10\^9/L
• Platelets (PLT) greater than or equal to 100 x 10\^9/L
• Hemoglobin (Hgb) greater than or equal to 9 g/dL
• Serum creatinine less than or equal to 1.5 upper limit of normal (ULN)
• Serum bilirubin less than or equal to 1.5 ULN
• Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) less than or equal to 3.0 x ULN
• Negative for proteinuria based on dip stick reading OR, if documentation of +1 result for protein on dip stick reading, then total urinary albumin ≤ 500 mg and measured creatinine clearance (CrCl) greater than or equal to 50 mL/min from a 24-hour urine collection
• A negative pregnancy test 48 hours prior to study treatment and must not be lactating if they are females of childbearing age.
• Ability to understand and the willingness to sign a written informed consent document in accordance with the guidelines of the Washington University Human Studies Committee.
• Age greater than or equal to 18 years old.
• ECOG performance status less than or equal to 2.

You may not qualify if:

• Receiving any other investigational agents.
• Receiving concurrent steroids with a dose equivalent of prednisone of \>= 150 mg/month.
• Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control. Barrier contraceptives must be used throughout the trial in both sexes. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study.
• Biopsy proven amyloidosis.
• Patients with a history of another primary malignancy within less than or equal to 5 years, with the exception of inactive basal or squamous cell carcinoma of the skin.
• Prior chemotherapy less than or equal to 3 weeks prior to registration and/or randomization. Patients must have recovered from all therapy-related toxicities.
• Prior biologic or immunotherapy less than or equal to 2 weeks prior to registration and/or randomization. Patients must have recovered from all therapy-related toxicities.
• Prior full field radiotherapy less than or equal to 4 weeks or limited field radiotherapy less than or equal to 2 weeks prior to randomization. Patients must have recovered from all therapy-related toxicities.
• Pleural effusion or ascites that cause respiratory compromise (greater than or equal to CTC grade 2 dyspnea).
• Major surgery (i.e. laparotomy) less than or equal to 4 weeks prior to randomization. Minor surgery less than or equal to 2 weeks prior to randomization. Insertion of a vascular access device is not considered major or minor surgery in this regard. Patients must have recovered from all surgery-related toxicities.
• Patients who have received investigational drugs less than or equal to 4 weeks prior to registration and/or randomization.
• Prior therapy with anti-vascular endothelial growth factor (VEGF) agents.
• Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
• Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
• Unstable angina pectoris

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

vatalanib

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

In November 2008, it was reported that the drug might have carcinogenic potential in animal models. At that time, the remaining three patients were taken off study.

Results Point of Contact

• Title: Ravi Vij, M.D.
• Organization: Washington University School of Medicine

rvij@dom.wustl.edu

314-454-8304

Study Officials

• Ravi Vij, M.D.

  Washington University School of Medicine

  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: SPONSOR

Study Record Dates

• First Submitted: October 13, 2005
• First Posted: October 17, 2005
• Study Start: September 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 17, 2014
• Results First Posted: September 4, 2014

Record last verified: 2014-09

Locations

US (1)