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Figure 8:  Response Criteria for Multiple Myelomaa

Response

Criteria

Complete responseb

  • Lack of detectable M-protein in serum or urine by immunoelectrophoresis & immunofixation, maintained for a minimum of 6 weeks.
  • Bone marrow biopsy with <5% plasma cells.
  • No increase in size or number of bone lesions.
  • Disappearance of plasmacytomas.

(Median survival=8 yrs)

Partial responseb

  • Reduction in serum M-protein by at least 50%, maintained for at least 6 weeks.
  • Reduction in urine Bence Jones protein by at least 90% or <200mg, maintained for at least 6 weeks.
  • If non-secretory, reduction in bone marrow plasma cells by at least 50%, maintained for at least 6 weeks.
  • No increase in size or number of bone lesions.

(Median survival=4 yrs)

Minimal responseb

  • Reduction in serum M-protein by at least 25-49%, maintained for at least 6 weeks.
  • Reduction in urine Bence Jones protein by at least 50-89%, maintained for at least 6 weeks.
  • If non-secretory, reduction in bone marrow plasma cells by at least 25-49%, maintained for at least 6 weeks.
  • No increase in size or number of bone lesions.

Disease progressionb

  • >25% increase in M-protein, Bence Jones protein, or bone marrow plasma cells.
  • An increase in size of bony lesions or plasmacytomas or appearance of new lesions.
  • Hypercalcemia.

Stable diseaseb

No significant changes in measurements of disease meeting criteria for at least minimal response or disease progression.

Bone marrow biopsy shows no change in plasma cell infiltration consistent with M protein decrease.

Overall survivalc

The percentage of subjects in a study who have survived for a defined period of time.  Usually reported as time since diagnosis or treatment. Also called the survival rate.

Time to progressionc

A measure of time after a disease is diagnosed (or treated) until the disease starts to get worse.

Progression-free survivalc

One type of measurement that can be used in a clinical study or trial to help determine whether a new treatment is effective. It refers to the probability that a patient will remain alive, without the disease getting worse.

Disease-free survival12

Length of time after treatment during which no cancer is found. Can be reported for an individual patient or for a study population.

Event-free survivald

Length of time after treatment that a participant in a clinical study remains free of pre-defined events.  Events are defined by the study and can include adverse treatment effects, tumor recurrence/progression, or survival.

Survival ratec

The percentage of people in a study or treatment group who are alive for a given period of time after diagnosis. This is commonly expressed as 5-year survival.

Notes:

a. The EBMT/IBMTR/ABMTR (a.k.a. Blade) criteria.
b. Derived from:  Blade J, Samson D, Reece D, et al., Criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation. Myeloma Subcommittee of the EBMT. European Group for Blood and Marrow Transplant. Br J Haematol 102:1115-23, 1998.
c. Quoted from the NCI's Web site (http://www.cancer.gov).
d. Definition derived from http://www.intelihealth.com/IH/ihtPrint/WSIHW000/8096/8241/347567.html?d=dmtContent&hide=t&k=basePrint#efsurvival.

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