Clinical Trial Detail

Clinical Trials

Clinical Trial Detail

High Throughput Drug Sensitivity and Genomics Data in Developing Individualized Treatment in Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia

Complete title: Individualized Treatment for Relapsed/Refractory Multiple Myeloma Based on High Throughput Drug Sensitivity and Genomics Data

Research Study Number 9944
Principal Investigator Andrew Cowan
Phase NA

Research Study Description

This pilot clinical trial studies whether using high throughput drug sensitivity and genomics data is feasible in developing individualized treatment in patients with multiple myeloma or plasma cell leukemia that has come back or does not respond to treatment. High throughput screen tests many different drugs that kill multiple myeloma cells in individual chambers at the same time. Matching a drug or drug combination to a patient using high throughput screen and genetic information may improve the ability to help patients by choosing drugs that work well for their disease.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older (Adult, Senior)

Sexes Eligible for Study: All

- Diagnosis of multiple myeloma with documented relapsed or refractory/relapsed disease according to international Myeloma Working Group (IMWG) criteria, or relapsed/refractory plasma cell leukemia

- Measurable disease defined by the following:

-- * Serum monoclonal protein >= 0.5 g/dL by serum protein electrophoresis (SPEP)

-- * >= 200 mg/monoclonal protein in urine on 24 hr urine protein electrophoresis (UPEP)

-- * Serum free light chain (FLC) >= 10 mg/dL and abnormal serum kappa to lambda ratio

- Minimum of 3 prior lines of therapy including an immunomodulatory drug (IMiD) and a proteasome inhibitor (PI)

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) >=2

- Female patients of child bearing potential and non-vasectomized male patients agree to practice appropriate methods of birth control

- Ability to understand purpose and risks of the study and provide signed and dated informed consent, and authorization to use protected health information

- 12 lead electrocardiogram (ECG) with corrected QT interval (QTc) =< 470 msec

- Absolute neutrophil count (ANC) > 1000

- Platelets > 75,000

- Hemoglobin (Hb) > 8

- Total bilirubin < 1.5 x upper limit of normal (ULN)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x ULN

- Estimated creatinine clearance by Cockcroft-Gault > 45

- Expected survival is > 100 days

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- Mucosal or internal bleeding, or platelet transfusion refractory

- Any medical conditions that would impose excessive risk to the patient, or would adversely affect his/her participation in the study

- Known active infection requiring antibiotics within 7 days of study initiation

- Other malignancy with life expectancy < 1 year due to the other malignancy

- Pregnant or breast feeding women

- Serious psychiatric illness, alcoholism, or drug addiction

- Human immunodeficiency virus (HIV), or active hepatitis B or C infection

- Previous treatments for multiple myeloma (MM) within 2 weeks

- Prior autologous or allogeneic stem cell transplantation (SCT) within 12 weeks of initiation of study treatment

- Prior allogeneic hematopoietic cell transplantation (HCT) with active graft versus host disease (GVHD) on therapeutic dosing of immunosuppression or prednisone > 20 mg daily equivalent

- Prior major surgical procedure or radiation therapy (RT) within 2 weeks (not including limited radiation used for palliation of bone pain)

Other exclusion criteria may apply.

Research Study Number 9944
Contact Seattle Cancer Care Alliance Intake Office
Telephone 800-804-8824 / 206-606-1024

Keywords: Hematologic Malignancies; Leukemia; Lymphoproliferative Disorders; Multiple Myeloma (MM); Immunoproliferative Disorders; Cardiovascular Diseases; Neoplasms, Plasma Cell; Paraproteinemias; Immune System Diseases; Hemostatic Disorders; Hemorrhagic Disorders; Hematologic Diseases; Vascular Diseases; Leukemia, Plasma Cell; Blood Protein Disorders

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  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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