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 L
Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: Stem cell transplant x 1 or x 2 (Procedure); lenalidomide and dexamethasone (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Memorial Sloan Kettering Cancer Center Official(s) and/or principal investigator(s): Hani Hassoun, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center
Overall contact: Hani Hassoun, MD, Phone: 212-639-3228
Summary
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.
Clinical Details
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 L
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The progression free survival (PFS) rate at 2 years after enrollment in untreated patients with multiple myeloma.
Secondary outcome: The CR+VGPR rateOverall myeloma response rates Overall survival
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age ≥ 18 and ≤ 75
- Histologic and serologic findings from MSKCC confirming the diagnosis of multiple
myeloma. Standard diagnostic criteria for multiple myeloma will be used, as per the
revised International Myeloma Working Group diagnostic criteria.
- 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.
- Patients may have received 1 cycle of prior therapy with dexamethasone for multiple
myeloma.
- Adequate organ function is required, defined as follows:
- ANC ≥ 1,500/μl and platelets ≥ 100,000/μl (unless low ANC and platelets are due to
multiple myeloma)
- Serum bilirubin ≤ 2. 0 mg/dl
- AST, ALT and alkaline phosphatase < 3 times the upper limit of laboratory normal
- Adequate renal function as assessed by calculated creatinine using Cockcroft-Gault
estimation of CrCl (see Appendix I): Subjects must have calculated creatinine
clearance ≥ 30ml/min by Cockcroft-Gault formula
- Performance status (ECOG) ≤ 2 (Appendix E).
- Eligible for SCT with LVEF ≥ 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 Revlimid REMS® program,
and be willing and able to comply with the requirements the of Revlimid REMS®
program
- 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 prior to prescribing lenalidomide for cycle 1
(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 or 81mg daily as prophylactic anticoagulation (patients
intolerant to ASA may use Coumadin or low molecular weight heparin).
Exclusion Criteria:
- Prior treatment for myeloma except for one cycle of dexamethasone
- 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 ≥ 5 years are eligible.
- Patients who have had prior malignancies within the past 5 years but are considered
to be "cured" with a low likelihood of recurrence may be eligible at the discretion
of the Principal Investigator.
- 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
Locations and Contacts
Hani Hassoun, MD, Phone: 212-639-3228
Memoral Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States; Recruiting Hani Hassoun, MD, Phone: 212-639-3228
Memorial Sloan-Kettering Cancer Center @ Suffolk, Commack, New York 11725, United States; Recruiting Hani Hassoun, MD, Phone: 212-639-3228
Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States; Recruiting Hani Hassoun, MD, Phone: 212-639-3228 MD Hani Hassoun, MD, Principal Investigator
Memorial Sloan Kettering at Mercy Medical Center, Rockville Centre, New York, United States; Recruiting Hani Hassoun, MD, Phone: 212-639-3228
Memoral Sloan Kettering Cancer Center at Phelps, Sleepy Hollow, New York 10591, United States; Recruiting Hani Hassoun, MD, Phone: 212-639-3228
Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center, Sleepy Hollow, New York 10591, United States; Recruiting Hani Hassoun, MD, Phone: 212-639-3228
Memorial Sloan Kettering West Harrison, West Harrison, New York 10604, United States; Recruiting Hani Hassoun, MD, Phone: 212-639-3228 Hani Hassoun, MD, Principal Investigator
Additional Information
Memorial Sloan Kettering Cancer Center
Starting date: December 2008
Last updated: May 27, 2015
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