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
Overview
- Phase
- Phase 2
- Intervention
- Stem cell transplant x 1 or x 2
- Conditions
- Multiple Myeloma
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 67
- Locations
- 7
- Primary Endpoint
- Progression Free Survival (PFS) Rate at 2 Years After Enrollment in Untreated Patients With Multiple Myeloma.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility 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).
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
Arms & Interventions
Stem cell transplant x 1 or x 2
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.
Intervention: Stem cell transplant x 1 or x 2
Continue lenalidomide and dexamethasone
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.
Intervention: lenalidomide and dexamethasone
Outcomes
Primary Outcomes
Progression Free Survival (PFS) Rate at 2 Years After Enrollment in Untreated Patients With Multiple Myeloma.
Time Frame: 2 years
Secondary Outcomes
- Overall Survival(up to 4 years)
- Number of Participants With VGPR + CR Rate(2 years)
- Overall Response Rates(2 years)