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Phase II Study of Revlimid (Lenalidomide), Melphalan, and Dexamethasone (ReMeDex) for Newly Diagnosed Multiple Myeloma Patients Not Undergoing Autologous Transplantation

Phase 2
18 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

Phase II Study of Revlimid (Lenalidomide), Melphalan, and Dexamethasone (ReMeDex) for Newly Diagnosed Multiple Myeloma Patients Not Undergoing Autologous Transplantation

Current multiple myeloma therapies, typically an induction regimen followed by consolidation
therapy with high dose chemotherapy and autologous stem cell rescue (autologous
transplantation), can induce remission but relapse and death are inevitable. A growing body
of literature suggests that consolidation therapy with autologous transplantation does not
confer additional survival benefit and may have increased procedure-related morbidity and
mortality in patients over 65 years old. Autologous transplantation is no longer
recommended as standard care for this population. In addition, certain patients may not be
eligible for autologous transplantation due to co-morbid medical conditions or may elect not
to undergo the procedure for personal reasons.

The historic standard of care for multiple myeloma patients who were not eligible for
autologous transplantation for consolidation was induction therapy with melphalan/
prednisone (MP), often followed by some form of maintenance therapy after achievement of
complete or partial remission. A recent phase 3 study showed that the addition of
thalidomide to MP (MPT) demonstrated higher overall and complete response rates. For
patients who are eligible for autologous transplantation, thalidomide/ dexamethasone (Thal
Dex) induction therapy is considered the standard of care, but a phase 2 study of
lenalidomide (Revlimid)/ dexamethasone (Rev Dex) induction therapy demonstrated higher
overall and complete response rates compared to Thal Dex. In addition, lenalidomide has a
favorable side effect profile compared to thalidomide. Based on these data, we hypothesize
that the combination of Revlimid/ melphalan/ dexamethasone (ReMeDex) induction therapy for
myeloma patients who are not planned for autologous transplantation due to age restriction
or other factors may demonstrate higher overall and/ or complete response rates with fewer
side effects.

Inclusion Criteria:

- Newly Diagnosed multiple myeloma, ISS stage I-III requiring therapy: Serum M-protein
≥1 gm/dL (≥10 gm/L), Urine M-protein ≥200 mg/24 hr, Serum FLC assay: involved FLC ≥10
mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal

- Previously untreated except prior treatment with corticosteroid less than one full
cycle of pulsed dose dexamethasone (40 mg daily days 1-4, 9-12, and 17-20) or
equivalent is allowed. Concomitant administration of IV bisphosphonates, Zometa
(zoledronic acid, up to 4 mg IVSS over 30 minutes every four weeks) or Aredia
(alendronate, up to 90 mg IVSS over 4 hours every four weeks), for prophylaxis
against skeletal complications due to lytic bone disease or for acute management of
hypercalcemia is allowed. Concomitant external beam radiation therapy for local
management of lytic bone disease is allowed.

- Age ≥ 18 years old

- Life expectancy ≥ 12 weeks

- ECOG Performance Status will be employed. ECOG 0-2 accepted.

- WBC ≥ 3.0 X 103/ µL, ANC ≥ 1.5 X 103/ µl, Hgb ≥ 8.0 gm/ dL, Plt ≥ 75 X 103/ µl, Serum
Creatinine ≤ 2.0 mg/ dL

- Ability to understand and the willingness to sign a written 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 to use a latex condom during sexual contact with a FCBP even if they
have had a successful vasectomy. See Appendix A: Risks of Fetal Exposure, Pregnancy
Testing Guidelines and Acceptable Birth Control Methods.

- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients
intolerant to ASA may use warfarin or low molecular weight heparin).

Exclusion Criteria:

- Prior therapy with Revlimid®, Thalomid (thalidomide), Velcade (bortezomib), Alkeran
(melphalan) excluded. Prior therapy with corticosteroid allowed as defined in
inclusion criteria.

- No prior or concurrent treatment with an investigational agent.

- Active Hepatitis B or C excluded, New York Heart Association grade III/IV congestive
heart failure excluded, History of bleeding disorder excluded, History of platelet
function disorder, History of deep vein thrombosis or other thromboembolic event

- Prior history of allergic reaction to IMiD™ compounds (Thalidomide, Lenalidomide)

- Concomitant treatment with NSAIDs drugs (with the exception of aspirin) or other
nephrotoxic agents is excluded.

- Serum creatinine > 2.0 mg/ dL is excluded

- Pregnancy and breastfeeding excluded

- Known HIV+ patients are excluded.

- Other active hematologic or solid tumor or history of such disease requiring therapy
of any form within five years of screening is excluded.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall and complete response rates

Outcome Time Frame:

every 28 days during therapy and every month after therapy for 2 years

Safety Issue:


Principal Investigator

Hearn J Cho, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

November 2008

Completion Date:

October 2011

Related Keywords:

  • Multiple Myeloma
  • multiple myeloma
  • frontline treatment
  • first-line treatment
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Bellevue Hospital New York, New York  10016
NYU Cancer Center New York, New York  10016
NYU Tisch Hospital New York, New York  10016