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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

Phase 2
18 Years
75 Years
Open (Enrolling)
Multiple Myeloma

Thank you

Trial Information

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

Inclusion Criteria:

- Age ≥ or = to 18 and < or = to 75

- Histologic and serologic findings from local site confirming the diagnosis of
multiple myeloma. 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.

- Patients may have received 1 cycle of prior therapy with dexamethasone for multiple

- 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

- 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) ≤ 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

- 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 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 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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the progression free survival (PFS) rate at 2 years after enrollment in untreated patients with multiple myeloma.

Outcome Time Frame:

conclusion of study

Safety Issue:


Principal Investigator

Hani Hassoun, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

December 2008

Completion Date:

December 2014

Related Keywords:

  • Multiple Myeloma
  • G-CSF
  • Lenalidomide
  • 08-121
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Sleepy Hollow, New York  10591
Memoral Sloan Kettering Cancer Center Basking Ridge, New Jersey  
Memorial Sloan-Kettering Cancer Center @ Suffolk Commack, New York  11725
Memoral Sloan Kettering Cancer Center at Phelps Sleepy Hollow, New York  10591
Memorial Sloan-Kettering at Mercy Medical Center Rockville Centre, New York