Lenalidomide and Rituximab in Treating Patients With Recurrent and/or Refractory Multiple Myeloma

NCT00567229 | Terminated Phase 2 Results

• 3 other identifiers: Mskcc 07-070P30CA008748MSKCC-07070
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, 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. Giving lenalidomide together with rituximab may be an effective treatment for multiple myeloma. PURPOSE: This phase II trial is studying the side effects of giving lenalidomide together with rituximab and to see how well it works in treating patients with recurrent or refractory multiple myeloma.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Final Response Rate After 4 Courses of Treatment

  2 years

Study Arms (1)

Lenalidomide and Rituximab

EXPERIMENTAL

This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.

Biological: rituximab; Drug: lenalidomide; Genetic: microarray analysis; Other: flow cytometry; Other: laboratory biomarker analysis

Interventions

rituximab BIOLOGICAL

Lenalidomide and Rituximab

lenalidomide DRUG

Lenalidomide and Rituximab

microarray analysis GENETIC

Lenalidomide and Rituximab

flow cytometry OTHER

Lenalidomide and Rituximab

laboratory biomarker analysis OTHER

Lenalidomide and Rituximab

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed CD20+ multiple myeloma * CD20+ disease defined as co-expression of CD20 on ≥ 25% of the clonal plasma cell population as defined by immunohistochemical or flow cytometric staining of a bone marrow or plasmacytoma specimen obtained at study entry * For flow cytometry, this is determined by calculating the frequency of CD20+ CD138+ double-positive cells within the total CD138+ plasma cell population * For immunohistochemistry, this is determined by dual staining for CD20 and the involved clonal light chain (kappa or lambda), with a determination of the percent double-positive (≤ 25% or ≥ 25%) * Symptomatic multiple myeloma that has relapsed or progressed after at least 1 prior anti-myeloma therapeutic regimen PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 16 weeks (4 months) * ANC ≥ 1,500/μL (unless low ANC due to multiple myeloma) * Platelets ≥ 100,000/μL (unless low platelets are due to multiple myeloma) * Serum bilirubin ≤ 2.0 mg/dL * AST, ALT, and alkaline phosphatase \< 3 times upper limit of normal * Serum creatinine ≤ 2.5 mg/dL * Able to understand the investigational nature of lenalidomide and rituximab combination therapy and to give informed consent * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-method contraception at least 28 days before, during, and for at least 28 days after completion or discontinuation of study treatment * Able to take acetylsalicylic acid (ASA) (325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin) * Prior malignancies with a disease free interval of ≥ 5 years allowed * No history of thromboembolic disease within the past 6 months, regardless of anticoagulation * No myocardial infarction within the past 6 months * No New York Hospital Association class III or IV heart failure * No uncontrolled angina * No severe uncontrolled ventricular arrhythmias * No active hepatitis B or C infection * No HIV 1or 2 positivity * No acute ischemia or active conduction system abnormalities as evidenced by ECG * No history of hypersensitivity reactions to lenalidomide, thalidomide, or rituximab * No other medical condition or laboratory evaluation that, in the treating physician's or principal investigators' opinion, makes the patient unsuitable to participate in this clinical trial * No concurrent active malignancy other than nonmelanoma skin cancers or carcinoma-in-situ of the cervix PRIOR CONCURRENT THERAPY: * At least 3 weeks since prior therapy, including radiotherapy * Prior lenalidomide or thalidomide allowed * No prior rituximab

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Rituximab; Lenalidomide; Microarray Analysis; Flow Cytometry

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Microchip Analytical Procedures; Investigative Techniques; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical

Results Point of Contact

• Title: Dr. Hani Hassoun
• Organization: Memorial Sloan Kettering Cancer Center

hassounh@mskcc.org

212-639-3228

Study Officials

• Hani Hassoun, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Heather Landau, MD

  Memorial Sloan Kettering Cancer Center

  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: December 1, 2007
• First Posted: December 4, 2007
• Study Start: November 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: November 20, 2015
• Results First Posted: November 20, 2015

Record last verified: 2015-10

Locations

US (1)