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Lenalidomide in Treating Patients With Progressive or Recurrent Multiple Myeloma After a Donor Stem Cell Transplant
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), February 2009
First Received: February 20, 2008   Last Updated: February 3, 2009   History of Changes
Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00619684
  Purpose

RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing.

PURPOSE: This phase II trial is studying how well lenalidomide works in treating patients with progressive or recurrent multiple myeloma after a donor stem cell transplant.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: lenalidomide
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
Drug Information available for: Lenalidomide CC 5013
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Lenalidomide Following Allogeneic Stem Cell Transplant for Multiple Myeloma Patients Who Relapse or Have Disease Progression

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Number of complete responses, partial responses, and minor responses [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity and tolerability of lenalidomide; proportion of patients remaining on lenalidomide for > 6 months [ Designated as safety issue: Yes ]
  • Proportion of patients with extensive chronic graft-versus-host disease (GVHD) responding, as measured by improvement in organ sites of involvement and ability to decrease or discontinue concurrent medications for chronic GVHD [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: December 2007
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To evaluate response rate in patients with progressive or relapsed multiple myeloma after prior allogeneic stem cell transplantation treated with lenalidomide.

Secondary

  • To evaluate toxicity and tolerance in patients treated with this drug.
  • To evaluate response in patients with chronic graft-versus-host disease treated with this drug.
  • To evaluate time to progression in patients treated with this drug.
  • To evaluate overall survival of patients treated with this drug.

OUTLINE: Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 30 days and then every 3 months thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma

    • Disease progression or relapsed disease after prior allogeneic stem cell transplantation from a matched or mismatched related or unrelated donor

      • Relapsed disease is defined as reappearance of monoclonal protein in serum or urine by immunofixation, new or increased bone lesions, or hypercalcemia
      • Disease progression is defined as a 25% increase in monoclonal protein in serum, a 50% increase in 24-hour urinary monoclonal protein from the lowest level attained at any time point after prior allogeneic stem cell transplantation, or new or increased bone lesions or hypercalcemia

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 50,000/mm³
  • Serum creatinine ≤ 2.0 mg/dL
  • Total bilirubin ≤ 1.5 mg/dL
  • AST (SGOT) and ALT (SGPT) ≤ 2 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present)
  • 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 of study treatment
  • Must be registered into the mandatory RevAssist® program and be willing and able to comply with the requirements of RevAssist®
  • No other malignancy within the past 5 years except currently treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
  • No serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
  • No condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk to participate in the study or confounds the ability to interpret data from the study
  • No known hypersensitivity to thalidomide
  • No prior development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
  • No resistance to prior lenalidomide
  • No known HIV positivity or type A, B, or C infectious hepatitis
  • No acute grade 3 or 4 GVHD
  • Must be able to take aspirin (81 or 325 mg daily) as prophylactic anticoagulation

    • Patients intolerant to aspirin may use coumadin or low molecular weight heparin

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 4 weeks since prior cancer therapy, including radiotherapy, hormonal therapy, or surgery (excluding corticosteroids for graft-versus-host disease [GVHD])
  • At least 4 weeks since other prior experimental drug or therapy
  • No concurrent sargramostim (GM-CSF)
  • No concurrent investigational GVHD drugs

    • Patients may remain on medications for GVHD including prednisone, which may be adjusted for clearly worsening GVHD
  • No other concurrent anticancer therapies including radiation, thalidomide, or other investigational agents (except prednisone for ongoing GVHD)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619684

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109-1024
Contact: Clinical Trials Office - Fred Hutchinson Cancer Research Cente     800-804-8824        
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109-1023
Contact: Clinical Trials Office - Seattle Cancer Care Alliance     800-804-8824        
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: William I. Bensinger, MD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Fred Hutchinson Cancer Research Center ( William I. Bensinger )
Study ID Numbers: CDR0000587513, FHCRC-2161.00, FHCRC-IR-6638
Study First Received: February 20, 2008
Last Updated: February 3, 2009
ClinicalTrials.gov Identifier: NCT00619684     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma

Study placed in the following topic categories:
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Lenalidomide
Disease Progression
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Recurrence
Multiple Myeloma
Hemorrhagic Disorders
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Blood Protein Disorders
Hematologic Diseases
Lenalidomide
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 07, 2009