Pomalidomide, Dexamethasone and Rituximab in Waldenstrom's Macroglobulinemia

NCT01078974 | Terminated Phase 1 Results DMC

• 2 other identifiers: 10-007PO-WM-PI-0005
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Pomalidomide is a newly discovered drug that may stop cancer cells from growing abnormally. Pomalidomide may also stimulate the immune system to fight the cancer cells and possibly improve the effectiveness of dexamethasone and rituximab to fight the Waldenstrom's Macroglobulinemia (WM) cancer cells. This drug have been used in multiple myeloma and information from these other research studies suggests that Pomalidomide may help to reduce or prevent the growth of cancer cells.

Conditions

Waldenstrom's Macroglobulinemia

Keywords

WM; pomalidomide; dexamethasone; rituximab

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose of Pomalidomide

  To determine the MTD of pomalidomide administered orally in patients with Waldenstrom's Macroglobulinemia in combination with dexamethasone and rituximab. Because maximum tolerated dose was not determined due to study termination, the highest dose of pomalidomide administered is presented below.

  2 years

• Tolerability of Pomalidomide

  Number of participants with dose limiting toxicities which resulted in being removed from pomalidomide therapy

  2 years

Study Arms (1)

pomalidomide, dexamethasone, rituximab

EXPERIMENTAL

Drug: pomalidomide Taken orally once a day Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15 Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15

Drug: pomalidomide; Drug: dexamethasone; Drug: rituximab

Interventions

pomalidomide DRUG

Taken orally once a day

Also known as: CC-4047, Pomalyst

pomalidomide, dexamethasone, rituximab

dexamethasone DRUG

Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15

Also known as: Decadron

pomalidomide, dexamethasone, rituximab

rituximab DRUG

Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15

Also known as: Rituxan

pomalidomide, dexamethasone, rituximab

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Able to adhere to the study visit schedule and other protocol requirements
• Clinicopathological diagnosis of Waldenstrom's macroglobulinemia using consensus panel criteria
• CD20 positive based on any previous performed bone marrow immunohistochemistry or flow cytometric analysis
• Meet criteria to treat based on consensus panel criteria
• Patient must have received at least one previous therapy for WM
• All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study
• Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level of 2 times (or greater) the upper limit of each institution's normal value is required
• ECOG Performance status of 0, 1 or 2
• Laboratory tests within ranges outlined in the protocol
• Disease free of prior malignancies for 5 years or more with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast
• Screening of patients at high risk of HBV or HCV infection
• Willing and able to take aspirin or alternate prophylactic anticoagulants

You may not qualify if:

• Any serious medical condition, laboratory abnormality, or psychiatric illness
• Pregnant or lactating females
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
• Resistance or intolerance to prior rituximab therapy
• Previous therapy with thalidomide or lenalidomide
• Known hypersensitivity to thalidomide, lenalidomide or pomalidomide
• The development of erythema nodosum if characterized by a desquamating rash while taking similar drugs
• Concurrent use of other anti-cancer agents or treatments
• History of non-compliance to medical regimens
• Patients unwilling to or unable to comply with the protocol
• Known positive for HIV or hepatitis infection
• Any history of CVA (Cerebral Vascular Accident/stroke) or clots
• Active DVT or PE that has not been therapeutically anticoagulated
• NYHA classification III and greater heart failure
• Any patient that is unable to ingest or process pomalidomide

Sponsors & Collaborators

• Steven P. Treon, MD, PhD: lead
• Celgene Corporation: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Interventions

pomalidomide; Dexamethasone; Calcium Dobesilate; Rituximab

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; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Pomalidomide and rituximab could have a synergistic effect on serum IgM levels and produce an IgM flare. The highest dose of pomalidomide in this trial was 1mg. The study was permanently closed to accrual given the safety concerns with the IgM flare.

Results Point of Contact

• Title: Steven P. Treon
• Organization: Dana-Farber Cancer Institute

steven_treon@dfci.harvard.edu

617-632-2681

Study Officials

• Steven P. Treon, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 2, 2010
• Study Start: May 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: March 1, 2016
• Last Updated: July 25, 2016
• Results First Posted: July 25, 2016

Record last verified: 2016-06

Locations

US (1)