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A Phase II Trial Of Thalidomide/Dexamethasone Induction Followed By Tandem Melphalan Transplant And Prednisone/Thalidomide Maintenance (A BMT Study)

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

Thank you

Trial Information

A Phase II Trial Of Thalidomide/Dexamethasone Induction Followed By Tandem Melphalan Transplant And Prednisone/Thalidomide Maintenance (A BMT Study)


- Determine the efficacy and toxicity of thalidomide and dexamethasone as a
pre-transplantation induction regimen in patients with multiple myeloma.

- Determine, preliminarily, the safety and efficacy of prednisone and thalidomide
maintenance therapy in these patients.

- Correlate chromosome 13 abnormalities with therapeutic response in patients treated
with this regimen.

- Correlate specific subsets of chromosome aberrations with event-free and overall
survival of patients treated with this regimen.

- Evaluate immune reconstitution and recovery after first and second transplantation in
these patients.

OUTLINE: This is a multicenter study.

- Induction chemotherapy: Patients receive oral thalidomide once daily on days 1-35 and
oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Treatment repeats every 35
days for 3 courses in the absence of disease progression or unacceptable toxicity.

- Stem cell mobilization and collection: Beginning 5-7 days, but no more than 3 weeks,
after completion of induction chemotherapy, patients receive cyclophosphamide IV over
45-60 minutes on day 0, filgrastim (G-CSF) subcutaneously (SC) on days 1-10, and
sargramostim (GM-CSF) SC beginning on day 1 and continuing until completion of
peripheral blood stem cell (PBSC) collection. Patients begin PBSC collection on day 11
or as soon as blood counts recover.

- First transplantation: Within 3-6 weeks after cyclophosphamide administration, patients
receive melphalan IV over 20 minutes on day -1. Patients undergo PBSC infusion on day
0. Patients receive GM-CSF SC or IV beginning on day 6 and continuing until blood
counts recover.

- Second transplantation: Between 2-4 months after first transplantation, patients
undergo a second tandem melphalan and PBSC transplantation with GM-CSF support as

- Maintenance therapy: Beginning 70-90 days post-transplantation, patients receive oral
prednisone every other day and oral thalidomide once daily. Treatment continues in the
absence of disease progression or unacceptable toxicity.

Patients are followed every 12 months for 10 years.

PROJECTED ACCRUAL: Approximately 99 patients will be accrued for this study within 18

Inclusion Criteria


- Newly diagnosed multiple myeloma requiring treatment

- Smoldering myeloma with evidence of progressive disease requiring chemotherapy

- More than 25% increase in M component levels and/or Bence-Jones excretion
or symptom development

- Non-secretory patients with at least 30% bone marrow plasmacytosis

- No IgM peaks unless there is evidence of more than 30% bone marrow plasmacytosis or
more than 3 lytic lesions



- 18 to 65

Performance status

- Zubrod 0-2 OR

- Zubrod 3-4 based solely on bone pain

Life expectancy

- Not specified


- No untreated, unresolved symptomatic hyperviscosity


- Hepatitis B negative


- Creatinine no greater than 3 mg/dL if in renal failure and on dialysis (after
hydration and/or correction of hypercalcemia)


- No history of chronic cerebrovascular accident

- No myocardial infarction within the past 6 months

- No unstable angina

- No congestive heart failure that is difficult to control

- No uncontrollable hypertension

- No cardiac arrhythmia that is difficult to control


- No history of chronic obstructive or chronic restrictive pulmonary disease

- No untreated, unresolved pneumonia

- Pulmonary function tests (PFTs) at least 50% of predicted

- DLCO at least 50% of predicted

- Arterial partial pressure of oxygen greater than 70 if unable to complete PFTs due to
bone pain or fracture


- HIV negative

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

- No untreated, unresolved pathologic fractures

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use at least 2 highly effective methods of contraception for 4
weeks before, during, and for at least 4 weeks after study participation


Biologic therapy

- No more than 8 weeks of prior thalidomide therapy


- No prior chemotherapy for this disease

Endocrine therapy

- Prior steroid therapy allowed provided treatment duration was no more than 2 weeks


- No prior radiotherapy to more than 50% of the pelvis


- Not specified

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Time Frame:

6 years

Safety Issue:


Principal Investigator

Mohamad A. Hussein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Federal Government

Study ID:




Start Date:

June 2002

Completion Date:

July 2012

Related Keywords:

  • Multiple Myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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