There are several key aspects to monitoring:

Discussion of expectations
It is first necessary to review carefully the timelines for testing and ongoing treatment. When is response expected?  What would necessitate a change?  Are these follow-on or back up plans?

Required testing
See "Understanding Your Test Results"

In this setting in which treatment has been started and you are awaiting and monitoring response, one must consider:

Confirmation of Response

• Change in SPEP and/or UPEP results. What is the "SPIKE" level in G/dl or mg or G/24 hrs?  This is calculated by multiplying the % which is the monoclonal protein or spike by the total protein per dl or 24 hrs.
  
  
• Achieving response. The goal is to achieve at least a 50% drop or reduction in the monoclonal/M-SPIKE level. This is a partial response (PR). The various higher levels (better) or response such as VGPR, CR or sCR are reviewed in STEP 6.
  
  
• Speed of response. With typical novel combination therapies currently used the initial response tends to be quite rapid. Within 2-3 months, major response will or should have occurred. If it does, treatment may be adjusted to improve tolerance for the longer term. If not, back up strategies/plans will be discussed.
  
  
• Clinical Indicators of Response.  Although the drop in M-SPIKE is key, other aspects must be assessed.
  • Have symptoms, such as pain and/or fatigue improved?
  • Is the patient function better (improved "performance status")?
  • Have CRAB features improved?
    • C (calcium). Typically the serum calcium returns to normal within a few days of starting successful therapy.
    • R (renal/kidney function). This is assessed by the level of serum creatine, which is part of the standard chemistry panel (CMPL). This also starts to improve promptly with fluid administration and anti-myeloma treatment (plus other urgent measures as needed including IV bisphosphonate and/or kidney dialysis in severe cases), but can be weeks or even months to fully recover or return toward normal as much as possible.
    • A (anemia). This is assessed by measuring the hemoglobin level (Gms/dl [Hgb]). This recovers over a period of weeks. It takes time for the bone marrow to produce new red blood cells. Initial blood transfusion may be required if Hgb levels are very low (< 8.5 Gms/dl). Along with anti-myeloma therapy, shots to boost red cell production can be considered (Procrit or Darbepoetin [Aranesp]).
    • B (bone). It takes time to assess improvement in bone.  Although bone pain can improve rapidly, new x-rays or scans are not usually performed for several months. For example, after four cycles of initial treatment (4 cycles of 3 or 4 weeks each) response can be confirmed, mostly to make sure nothing new has emerged on x-rays or scans. Any new pain may require testing sooner.
      

Watching out for side effects or toxicities

• For this, feedback from the patient is key. It is crucial for the patient to inform the doctor and/or nurses or other caregivers about side effects.
  
  
• Dose adjustments can be made promptly so that side effects will be reversible rather than become ongoing, chronic or worsening problems.  This is especially true for any type of nerve damage or necropathy indicated by loss of sensation, pain, or any other concerns with nerve function.
  
  
• Balancing benefits and side effects. At all times one must balance the need to get the myeloma into remission and the possibility of side effects.
  
  

Follow up testing

• In general, basic testing, including blood counts, chemistry panel, M-SPIKE measurements, Freelite testing and possibly 24 hr urine (if patient has light chain ONLY or BJ disease) is done with each cycle, i.e. every 3-4 wks for the first 4 cycles.
  
  
• As noted imaging (xrays/scans) are only repeated after several months unless there are new concerns.
  
  
• It is usually only necessary to repeat the bone marrow test to confirm if a complete response (CR) has been achieved. Obviously, if progression or possible relapse is a concern, then follow up bone marrow may be required.

Click to view the slides for this step.

ASH 2011 presentations that address STEP 8

REFERENCES

©2011 International Myeloma Foundation