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
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

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.
    


Intervention name(s): Stem cell transplant x 1 or x 2; lenalidomide and dexamethasone
Intervention type(s): Procedure; Drug
Intervention description(s): After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization.
On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.; Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.
Other intervention name(s): In the initial 4 cycles of therapy, pts will receive oral lenalidomide at the; starting dose of 25mg on days 1-21 every 28 days (1 cycle) with dose; adjustments for creatinine clearance (CRCL) & dose reductions for toxicity.; Pts will receive low-dose oral dexamethasone at 40mg weekly on days 1, 8, 15 &; 22 of each 28-day cycle with dose reductions as below for toxicity (the weekly; dose could be split over 2 days in the week i.e. 20mg on days 1, 4, 8, 11, 15,; 18, 22, & 25 for better tolerance). For SCT, pts are adm to hosp. High-dose; melphalan is admin in a single dose on day -2 or split dose on days -3 & -2,; through a cvc. Melphalan doseadjustments are made for age & CRCL,. Pts with; CRCL,> 51ml/min receive melphalan at 200mg/m2. Pts with CRCL < 51ml/min; (to be evaluated within 2 weeks of SCT) will receive 140mg/m2. Pts > 70 years; old receive 140mg/m2 also. Each SCT in a tandem SCT is a clinically discrete; event & these rules of dose adjustment apply to each SCT. It is possible,; that pts will get different doses of melphalan in tandem SCT; In the initial 4 cycles of therapy, pts will receive oral lenalidomide at the; starting dose of 25mg on days 1-21 every 28 days (one cycle) with dose; adjustments for creatinine clearance and dose reductions. Pts will receive; low-dose oral dexamethasone at 40mg weekly on days 1, 8, 15 & 22 of each; 28-day cycle with dose reductions (the weekly dose could be split over 2 days; in the week i.e. 20mg on days 1, 4, 8, 11, 15, 18, 22, & 25 for better; tolerance). For continued Ld, pts will resume Ld at the last dose tolerated; during the initial 4 cycles, with prophylactics & dose reductions as indicated.; Lenalidomide will be continued until progression of disease, if as tolerated.; Low-dose dexamethasone will be continued for 1 year (from the start of initial; treatment), as tolerated. Dose adjustments will follow guidelines. Pts will; be seen every 3 months by their physician & their disease will be reassessed.; Pts will also have a CBC & pregnancy test performed monthly.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Lenalidomide; Melphalan; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CYCLOPHOSPHAMIDE (CYTOXAN); DEXAMETHASONE; G-CSF; Lenalidomide; MELPHALAN; PEG-FILGRASTIM (NEULASTA); 08-121