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Lenalidomide (Revlimid) Plus Low-Dose Dexamethasone (Ld x 4 Cycles) Then Stem Cell Collection Followed by Randomization to Continued Ld or Stem Cell Transplantation (SCT) Plus Maintenance Ld for SCT Patients Not Achieving at Least Very Good Partial Response (VGPR) or Having High-Risk Disease
This study has been suspended.
Sponsored by: Memorial Sloan-Kettering Cancer Center
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00807599
  Purpose

The purpose of this study is to compare the effects, good and bad, of two ways to treat patients with standard-risk symptomatic multiple myeloma. Patients with standard-risk myeloma have myeloma with specific features: levels of 2 blood tests have to be in a specific range and there can be no myeloma tumors found outside of the bones or bone marrow, the areas where myeloma is usually discovered. In past clinical studies, patients with standard-risk myeloma have done well with intensive therapy in the form of stem cell transplant. But multiple myeloma is not curable and, although it may respond to standard treatments including stem cell transplant, myeloma always recurs.


Condition Intervention Phase
Multiple Myeloma
Procedure: Stem cell transplant x 1 or x 2
Drug: lenalidomide and dexamethasone
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
Drug Information available for: Cyclophosphamide Filgrastim Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Melphalan Granulocyte colony-stimulating factor Pegfilgrastim Melphalan hydrochloride Sarcolysin Lenalidomide CC 5013
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: A Phase II Clinical Trial for Untreated Patients With Multiple Myeloma Eligible for Stem Cell Transplant: Lenalidomide (Revlimid) Plus Low-Dose Dexamethasone (Ld x 4 Cycles) Then Stem Cell Collection Followed by Randomization to Continued Ld or Stem Cell Transplantation (SCT) Plus Maintenance Ld for SCT Patients Not Achieving at Least Very Good Partial Response (VGPR) or Having High-Risk Disease

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To determine the complete and very good partial response (CR+VGPR) rate at 2 years after enrollment in untreated patients with multiple myeloma. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the CR+VGPR rate at 3 years [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • To assess overall myeloma response rates at 2 and 3 years [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • To assess overall and progression-free survival [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • To describe CD32B-related biology in multiple myeloma [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: December 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Stem cell transplant x 1 or x 2: Experimental

All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :

  • stem cell transplant right after collection
  • continue lenalidomide and dexamethasone, saving stem cell transplant for a later time.
Procedure: Stem cell transplant x 1 or x 2
After 4 cycles of Ld, eligible patients will be referred to the main campus for stem cell mobilization and collection with standard-of-care cyclophosphamide (3000mg/m2 as an inpatient for 1-2 days) and Neupogen (G-CSF). Ld will be held for at least 2 weeks prior to stem cell mobilization. Patients will then be randomized to continued Ld or high-dose melphalan with SCT. Patients not achieving VGPR by 4 months after the 1st SCT will undergo a 2nd SCT. Patients not achieving VGPR after tandem transplant and patients in the high-risk group will receive maintenance Ld (L=10mg/day and d=20mg flat dose weekly).
Continue lenalidomide and dexamethasone: Experimental

All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :

stem cell transplant right after collection

  • continue lenalidomide and dexamethasone
  • saving stem cell transplant for a later time.
Drug: lenalidomide and dexamethasone
Patients will then be randomized to continued Ld or high-dose melphalan with SCT. Patients not achieving VGPR by 4 months after the 1st SCT will undergo a 2nd SCT.Patients not achieving VGPR after tandem transplant and patients in the high-risk group will receive maintenance Ld (L=10mg/day and d=20mg flat dose weekly). Patients will continue on the Ld and SCT arms of therapy until progression of disease.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ or = to 18 and < or = to 75
  • Hematology Service and the Departments of Pathology and Clinical Chemistry at Memorial Sloan-Kettering Cancer Center. Standard diagnostic criteria for multiple myeloma will be used, as per the International Myeloma Foundation consensus guidelines.
  • Patients must have symptomatic multiple myeloma without advanced organ damage (such as multiple fractures or advanced bone disease causing immobilization, renal failure, spinal cord compression, or organ compromise due to soft tissue plasmacytoma). If immediate therapy with radiation and high-dose steroids (eg, for cord compression) or with bortezomib-based therapy (eg, for renal failure) is required, the patient is not eligible for this trial.
  • Adequate organ function is required, defined as follows:
  • ANC ≥ or = to 1,500/μl and platelets≥ or = to 100,000/μl (unless low ANC and platelets are due to multiple myeloma)
  • Serum bilirubin ≤ or = to 2.0 mg/dl
  • AST, ALT and alkaline phosphatase < 3 times the upper limit of laboratory normal
  • Serum creatinine ≤ or = to 2.5 mg/dl
  • Performance status (ECOG) ≤ or = to 2 (Appendix E).
  • Eligible for SCT with LVEF > or = to 50% by MUGA or ECHO, and diffusing capacity > 50% predicted by pulmonary function testing
  • Ability to understand the investigational nature of this study and to give informed consent
  • All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist
  • Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy. See Appendix C: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
  • Able to take aspirin 325mg daily as prophylactic anticoagulation (patients intolerant to ASA may use Coumadin or low molecular weight heparin).

Exclusion Criteria:

  • Prior treatment for myeloma
  • History of thromboembolic disease within the past 6 months regardless of anticoagulation
  • Myocardial infarction within 6 months prior to enrollment, or New York Hospital Association (NYHA) Class III or IV heart failure (see APPENDIX F), uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
  • Pregnant or breast-feeding women are excluded due to the potential teratogenicity of lenalidomide.
  • Concurrent active malignancy other than non-melanoma skin cancers or carcinoma-insitu of the cervix, or presence of myelodysplastic or myeloproliferative disease. Patients with prior malignancies with a disease-free interval of ≥ or = to 5 years are eligible.
  • Active hepatitis B or C infection
  • HIV 1 or 2 positivity
  • Any other medical condition or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807599

Locations
United States, New Jersey
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital
Sleepy Hollow, New York, United States
Memorial Sloan-Kettering at Mercy Medical Center
Rockville Centre, New York, United States
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Raymond Comenzo, MD Memorial Sloan-Kettering Cancer Center
  More Information

Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site

Responsible Party: Memorial Sloan-Kettering Cancer Center ( Raymond Comenzo, MD )
Study ID Numbers: 08-121
Study First Received: December 11, 2008
Last Updated: January 6, 2009
ClinicalTrials.gov Identifier: NCT00807599  
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
CYCLOPHOSPHAMIDE (CYTOXAN)
DEXAMETHASONE
G-CSF
Lenalidomide
MELPHALAN
PEG-FILGRASTIM (NEULASTA)

Study placed in the following topic categories:
Dexamethasone
Melphalan
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Lenalidomide
Vascular Diseases
Paraproteinemias
Cyclophosphamide
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Dexamethasone acetate
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Hormones
Glucocorticoids
Pharmacologic Actions
Neoplasms
Autonomic Agents
Therapeutic Uses
Cardiovascular Diseases
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009