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S0120, A Prospective Observational Biologic Study of Asymptomatic Patients With Monoclonal Gammopathy and Plasmaproliferative Disorders

Open (Enrolling)
Multiple Myeloma, Plasma Cell Myeloma, Precancerous Condition

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Trial Information

S0120, A Prospective Observational Biologic Study of Asymptomatic Patients With Monoclonal Gammopathy and Plasmaproliferative Disorders


- Establish a serum, cell, and bone marrow tissue bank of prospectively collected samples
from patients with monoclonal gammopathy of undetermined significance (MGUS),
asymptomatic multiple myeloma, solitary plasmacytoma, or other plasma cell dyscrasias.

- Evaluate the feasibility of accruing patients with these diseases.

- Determine whether patterns of gene expression or cytogenetics exist that allow
molecular delineation of MGUS subtypes.

- Characterize cellular and humoral immune response to known tumor antigens in these

- Cryopreserve serum/T cells for future evaluation.

- Preliminarily identify biological correlates that may relate to progression to
symptomatic disease.

OUTLINE: Patients are stratified according to diagnosis (monoclonal gammopathy of
undetermined significance [MGUS] or other plasma cell dyscrasias vs asymptomatic multiple
myeloma vs solitary plasmacytoma).

Blood and bone marrow samples are collected and analyzed for microarray analysis,
cytogenetic analysis, and immunobiology studies.

Unused samples may be stored for future research studies.

Patients are followed periodically for 5 years.

Inclusion Criteria


- Diagnosis of one of the following plasmaproliferative diseases:

- Monoclonal gammopathy of undetermined significance (MGUS)

- Asymptomatic multiple myeloma

- Solitary plasmacytoma

- Other plasma cell dyscrasias

- Disease does not require therapy

- Willing to submit research samples for gene expression analysis and immunologic



- Not specified

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- No other malignancy within the past 2 years except for adequately treated basal cell
or squamous cell skin cancer, in situ cervical cancer, or adequately treated stage I
or II cancer from which the patient is currently in complete remission


Biologic therapy

- No prior biologic therapy for this disease


- No prior chemotherapy for this disease

Endocrine therapy

- No prior endocrine therapy for this disease


- No prior radiotherapy for this disease


- No prior surgery for this disease


- Prior or concurrent bisphosphonates allowed

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Disease progression

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Madhav Dhodapkar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Rockefeller University


United States: Federal Government

Study ID:




Start Date:

June 2002

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Plasma Cell Myeloma
  • Precancerous Condition
  • stage I multiple myeloma
  • isolated plasmacytoma of bone
  • monoclonal gammopathy of undetermined significance
  • Monoclonal Gammopathy of Undetermined Significance
  • Paraproteinemias
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Precancerous Conditions



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