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A Phase II Clinical Trial Of Thalidomide, Adramycin And Dexamethasone (TAD) As Initial Therapy For The Treatment Of Multiple Myeloma

Phase 2
18 Years
Not Enrolling
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

A Phase II Clinical Trial Of Thalidomide, Adramycin And Dexamethasone (TAD) As Initial Therapy For The Treatment Of Multiple Myeloma

OBJECTIVES: I. Determine the response rate of patients with previously untreated stage II or
III multiple myeloma treated with thalidomide, doxorubicin, and dexamethasone. II. Determine
the safety and toxicity of this regimen in this patient population.

OUTLINE: Patients receive oral dexamethasone on days 1-4, 9-12, and 17-20, doxorubicin IV on
day 1, and oral thalidomide daily. Treatment repeats every 30 days for 4 courses in the
absence of unacceptable toxicity or disease progression.

PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within
approximately 1 year.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed multiple myeloma Stage II disease
Symptomatic due to progressive disease OR Stage III disease No stage I multiple myeloma or
smoldering myeloma

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy:
More than 4 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3* Platelet
count at least 100,000/mm3* *Unless due to multiple myeloma Hepatic: Bilirubin no greater
than 2.0 mg/dL ALT and AST no greater than 3 times upper limit of normal (ULN) Alkaline
phosphatase no greater than 3 times ULN Renal: Elevated creatinine allowed Cardiovascular:
LVEF at least 50% by MUGA or ECHO No active angina No myocardial infarction within the
past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must
use effective contraception at least 4 weeks prior to, during, and for at least 4 weeks
after study No grade II or greater pre-existing neuropathy No other concurrent or prior
active malignancy within the past 2 years except adequately treated non-melanoma skin
cancer or carcinoma in situ of the cervix Prior T1a or T1b prostate cancer (detected
incidentally at transurethral resection of prostate (TURP) and comprising less than 5% of
resected tissue) allowed if PSA normal since TURP HIV negative No AIDS-related illness No
other medical condition that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for multiple myeloma Endocrine therapy: No more than 1 course of prior pulse
dexamethasone Prior steroids of less than 1 month duration for emergent indications or
life-threatening lesions (e.g., hypercalcemia or spinal cord compromise) allowed
Radiotherapy: Prior radiotherapy allowed Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Raymond L. Comenzo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 2000

Completion Date:

January 2006

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021