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MYELOMA CHAPTER 11C REVISED: OCTOBER 2015 Chapter 11C - Page 1 ORP Manual, Volume I Version 2.0 MYELOMA Quantitative Markers-Myeloma Assessment

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MYELOMA CHAPTER 11C REVISED: OCTOBER 2015 Chapter 11C - Page 1 ORP Manual, Volume I Version 2.0 MYELOMA Quantitative Markers-Myeloma Assessment

SWOG
ONCOLOGY RESEARCH PROFESSIONAL (ORP) MANUAL

VOLUME I

RESPONSE ASSESSMENT CHAPTER 11C REVISED: OCTOBER 2015
MYELOMA

MYELOMA

Quantitative Markers-Myeloma Assessment

Quantitative markers are biochemicals that are recorded in tests on body fluids such as serum
and urine.

Applicable Disease Sites

The myeloma disease site is the only one that uses markers in quantified disease assessment.
The markers examined are the serum M protein, urine M protein, and serum free light chain
levels. These markers are assessed regularly to see by what percentage they have increased
or decreased from their value at baseline. In addition, in patients whose markers indicate that
they are responding to treatment, the bone marrow is also assessed to verify that the plasma
cells are indeed at a minimum.

Response Assessment

Specific criteria for assessing response are found in Section 10.0 of each protocol. The two
versions of the response criteria listed below are representative of the versions that are used
most often. In 2006, the International Myeloma Working Group published the International
Uniform Response Criteria for Multiple Myeloma, on which the first version listed is based. This
version of the criteria is standard in all SWOG multiple myeloma protocols activated after
January 1, 2006. The second version listed is representative of the criteria used in some
SWOG multiple myeloma protocols activated prior to January 1, 2006. Since the criteria used
are unique to each protocol, the protocol must be consulted prior to assessing response.

Response Assessment for Studies Activated Since January 1, 2006

This version of the response criteria is based on the International Uniform Response Criteria for
Multiple Myeloma, and is standard in all protocols activated after January 1, 2006.

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Measurability of Disease

Measurable Disease: Measurable, quantifiable protein criteria must be present. Acceptable
protein criteria are:

• Serum M protein ≥ 1 g/dL (≥ 10 g/L), quantified by using densitometry on serum
protein electrophoresis (SPEP).
AND / OR

• Urine M protein [Bence-Jones Protein] ≥ 200 mg/24 hrs (> 0.2 g/24 hrs), quantified by
24-hour urine protein electrophoresis (UPEP).
AND/OR
Bone marrow plasma cells ≥ 30%
OR

• Patients who have both serum M protein levels < 1 g/dL AND urine M protein levels <
200 mg/24 hrs at baseline may be followed by serum free light chain (FLC) assay if
involved free light chain level ≥ 10 mg/dL (≥ 100mg/L).

Oligosecretory and Non-secretory Disease: Patients that do not meet the criteria for
measurable disease above may only be assessed for the following objective statuses: Stringent
Complete Response, Stable, and Progression.

Criteria for Objective Status

sCR Stringent Complete Response:
CR
VGPR • Meets all of the criteria for Complete Response (CR) and
• normal serum free light chain ratio and
• absence of clonal cells in bone marrow by immunohistochemistry or

immunofluorescence

Complete Response:

• Disappearance of all evidence of serum and urine M proteins on
immunofixation electrophoresis studies and

• ≤ 5% plasma cells in bone marrow and
• disappearance of any soft tissue plasmacytomas

Very Good Partial Response:

• Meets all of the criteria for Partial Response (PR) and
• Serum and urine M proteins detectable by immunofixation but not on

electrophoresis or
• ≥ 90% reduction in serum M protein and urine M protein < 100 mg/24

hrs.

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PR Partial Response:

• If the patient had soft tissue plasmacytomas present at baseline and
they were assessed at this disease assessment: ≥ 50% reduction in
size of soft tissue plasmacytomas and

• If the patient had ≥ 30% plasma cells in bone marrow at baseline and
a bone marrow biopsy was done: ≥ 50% reduction in plasma cells
and

• ≥ 50% reduction in serum M protein and reduction in urine M protein
≥ 90% or to < 200 mg/24hr or

• If patient had serum M protein < 1 g/dL, urine M protein < 200 mg/24
hrs, and an involved serum free light chain level ≥ 10 mg/dL at
baseline: ≥ 50% decrease in the difference between involved and
uninvolved serum free light chain levels

STA Stable Disease:

• Patient does not meet criteria for Stringent Complete Response,
Complete Response, Very Good Partial Response, Partial Response,
or Progression.

PROG Progression: Any one or more of the following:

• Serum M protein increase ≥ 25% from baseline (or an increase of ≥ 1
g/dL if serum M protein was ≥ 5 g/dL at baseline), with an absolute
increase of ≥ 0.5 g/dL or

• Urine M protein increase ≥ 25% from baseline, with an absolute
increase of ≥ 200 mg/24 hrs or

• If patient had serum M protein < 1 g/dL, urine M protein < 200 mg/24
hrs, and an involved serum free light chain level ≥ 10 mg/dL at
baseline: ≥ 25% increase in the difference between involved and
uninvolved serum free light chain level, with an absolute increase of ≥
10 mg/dL or

• Bone marrow plasma cell percentage increase ≥ 25% from baseline,
with the absolute plasma cell % ≥ 10% or

• New bone lesions or soft tissue plasmacytomas, or definite increase
in size of existing bone lesions or soft tissue plasmacytomas or

• Development of hypercalcemia (corrected serum calcium > 11.5
mg/dL or 2.65 mmol/L that can be attributed solely to multiple
myeloma

Notes

“M protein” may also be known by the following synonyms: M-spike, monoclonal protein,
myeloma protein, monoclonal paraprotein, M-component.

Urine M protein measurement is estimated using 24-hour urine protein electrophoresis (UPEP)
only. Random or 24 hour urine tests measuring kappa and lambda light chain levels are not
reliable and are not recommended.

Patients with ‘measurable disease’ in both the serum and urine (serum M protein ≥ 1g/dL and
urine M protein ≥ 200 mg/24h) at baseline need to be followed by both SPEP and UPEP for
response assessment.

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Except for assessment of Complete Response, patients with ‘measurable disease’ restricted to
the serum (serum M protein ≥ 1 g/dL and urine M protein < 200 mg/24h) at baseline may be
followed by SPEP only. Likewise, except for assessment of Complete Response, patients with
‘measurable disease’ restricted to the urine (serum M protein < 1 g/dL and urine M protein ≥ 200
mg/24h) at baseline may be followed by UPEP only.

Patients with serum M protein ≥ 1 g/dL and/or urine M protein ≥ 200 mg/24h at baseline will be
assessed for response based on SPEP and/or UPEP results only. Except for assessment of
Stringent Complete Response, serum free light chain (FLC) assay response requirements are
only applicable to patients who had serum M protein < 1 g/dL, urine M protein < 200 mg/24 hrs,
and an involved serum free light chain level ≥ 10 mg/dL at baseline. A normal serum free light
chain ratio is required for all patients for a Stringent Complete Response.

To qualify for a Complete Response, both serum and urine immunofixation must be carried out
and must be negative, regardless of the size of the baseline M protein in the serum or urine.

Skeletal survey is not required for assessment of response unless clinically indicated, but is
recommended once a year in clinical practice. Stringent Complete Response, Complete
Response, Very Good Partial Response, Partial Response, and Stable Disease all require no
known evidence of progressive or new bone lesions if radiographic studies were performed, but
radiographic studies are not required to satisfy these response requirements.

The size of the soft tissue plasmacytomas is defined as the sum of the products of the cross-
diameters of each plasmacytoma. The size of the bone lesions will be determined in a similar
manner. A definite increase in the size is defined as a ≥ 50% increase (and at least 1 cm2) of
this sum.

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Criteria for Best Response

This is calculated from a sequence of objective status evaluations.

sCR Stringent Complete Response: An objective status of Stringent Complete
Response on at least two sequential disease assessments. Only one bone
marrow biopsy, done during one of these two disease assessments, is
required to confirm the response.

CR Complete Response: An objective status of Complete Response on at least
two sequential disease assessments. Only one bone marrow biopsy, done

during one of these two disease assessments, is required to confirm the

response.

VGPR Very Good Partial Response: An objective status of Very Good Partial

Response on at least two sequential disease assessments.

PR Partial Response: An objective status of Partial Response on at least two

sequential disease assessments.

UsCR Unconfirmed sCR: One objective status of Stringent Complete Response

(based on evidence from serum and urine studies and, if drawn, bone

marrow biopsy) but the confirmation studies are either not done, or when

done, do not meet the requirements necessary to confirm response. This
must be documented before progression and at least three weeks after

registration.

UCR Unconfirmed CR: One objective status of Complete Response (based on

evidence from serum and urine studies and, if drawn, bone marrow biopsy)

but the confirmation studies are either not done, or when done, do not meet

the requirements necessary to confirm response. This must be documented

before progression and at least three weeks after registration.

UVGPR Unconfirmed VGPR: One objective status of Very Good Partial

Response, but the confirmation studies are either not done, or when done,

do not meet the requirements necessary to confirm response. This must be

documented before progression and at least three weeks after registration.

UPR Unconfirmed PR: One objective status of Partial Response, but the

confirmation studies are either not done, or when done, do not meet the

requirements necessary to confirm response. This must be documented

before progression and at least three weeks after registration.

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STA Stable / No Response: At least one objective status of Stable at least three
weeks after registration, but not qualifying as any of the above. If
radiographic studies were performed there should be no known progressive
or new bone lesions.

INC Increasing Disease: First objective status recorded (other than Unknowns or
those before three weeks) of Progression, provided this occurs within eight

weeks of registration.

NASS Inadequate Assessment, Response Unknown: Progression greater than
eight weeks after registration and either all objective statuses prior to
registration are unknown or the only known objective statuses occurred less
than three weeks after registration.

Response Assessment for Studies Activated Prior to January 1, 2006

This version of the response criteria is representative of the criteria used in some SWOG
multiple myeloma protocols activated prior to January 1, 2006. Please note that prior to January
1, 2006 SWOG did not have a standard multiple myeloma response criteria, so you MUST
consult section 10.0 of the treatment protocol prior to assessing patient response.

Measurability of Disease

Measurable Disease: Measurable, quantifiable protein criteria must be present. Acceptable
protein criteria are quantifiable (≥ 1.0 g/dL [10.0 g/L] serum M-protein of IgG, IgA, IgD, IgE
isotype and/or urine M-protein [Bence-Jones Protein] (≥ 200 mg/24 [≥ 0.2 g/24 hrs]). Patients
with IgM peaks must have either ≥ 20% bone marrow plasmacytosis or > 3 lytic lesions on the
skeletal survey.

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Criteria for Objective Status

CR Complete Remission: Absence of bone marrow or blood findings of multiple
myeloma. This includes disappearance of all evidence of serum and urine
REM M-proteins on immunofixation electrophoresis studies. Normalization of
PR serum concentrations of normal immunoglobulins is not required for CR.
STA There must also be no evidence of increasing anemia. Bone marrow
PROG cellularity must be ≥ 20% with plasma cells ≤ 5%.

Remission: A ≥ 75% reduction in the serum M-protein, and if a urine M-
protein (Bence-Jones protein) is present, either a ≥ 90% reduction in this
protein, or a urine M-protein < 0.2 g/day. Bone marrow plasma cells must be
≤ 5%.

Partial Remission: A ≥ 50% reduction in the serum M-protein, and if present,
a ≥ 50% reduction in the urine M-protein (Bence-Jones protein). Bone
marrow plasma cells must not be increased from baseline level.

Stable / No Remission: A < 50% reduction in the serum M-protein, or if the
patient has light-chain disease only, a < 50% reduction in the urine M-protein
(Bence-Jones protein). Patients not qualifying for remission or progression.

Progression: In patients with no confirmed Partial Remission, Remission, or
Complete Remission, Progression is defined as a > 25% increase from
baseline in myeloma protein production or other signs of disease progression
such as hypercalcemia, etc.

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REL Relapse: In patients with a confirmed Partial Remission, Remission, or
Complete Remission (The patient must have had an objective status of
Notes Partial Remission, Remission, or Complete Remission on two successive
disease assessments performed at least six weeks apart - with or without a
bone marrow biopsy.), Relapse is defined as the first occurrence of any of
the following: 1) a myeloma protein increase by100% from the lowest level
recorded on study, provided the absolute magnitude of this increase is at
least 1 g/dL for a serum monoclonal protein or at least 500 mg/24 hrs of urine
M-protein; 2) a myeloma protein increase above the response criteria for PR
(see criteria for Partial Remission), with the same requirements for the
absolute magnitude of the protein increase; 3) reappearance of any myeloma
peak that had disappeared while on protocol treatment, provided it meets the
same requirements listed above; 4) increase in the size and number of lytic
bone lesions recognized on radiographs.

In all remissions, the serum calcium must remain normal, and where a skeletal survey is
required, the size and number of lytic lesions must not increase.

Criteria for Best Response

This is calculated from a sequence of objective status evaluations.

CR Complete Remission: An objective status of Complete Remission on at least
two disease assessments performed at a minimum of six weeks apart. A

bone marrow biopsy and a skeletal survey must be done during one of these

two disease assessments. The skeletal survey must either show

recalcification or no change in osteolytic lesions.

REM Remission: An objective status of Remission on at least two disease
assessments performed at a minimum of six weeks apart. A bone marrow
biopsy must be done during one of these two disease assessments. If the
patient has new symptoms of pain, a skeletal survey must also be done.

PR Partial Remission: An objective status of Partial Remission on at least two
disease assessments performed at a minimum of six weeks apart. A bone

marrow biopsy must be done during one of these two disease assessments.

If the patient has new symptoms of pain, a skeletal survey must also be

done.

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UCR Unconfirmed CR: One objective status of Complete Remission based on
evidence from serum and urine protein, with or without a bone marrow
biopsy, documented before progression and at least three weeks after
registration, but the confirmation studies are either not done, or when done,
do not meet the requirements necessary to confirm response.

UREM Unconfirmed REM: One objective status of Remission based on evidence
from serum and urine protein, with or without a bone marrow biopsy,
documented before progression and at least three weeks after registration,
but the confirmation studies are either not done, or when done, do not meet
the requirements necessary to confirm response.

UPR Unconfirmed PR: One objective status of Partial Remission based on
evidence from serum and urine protein, with or without a bone marrow
biopsy, documented before progression and at least three weeks after
registration, but the confirmation studies are either not done, or when done,
do not meet the requirements necessary to confirm response.

STA Stable / No Remission: At least one objective status of Stable at least three
weeks after registration, but not qualifying as any of the above.

INC Increasing Disease: First objective status recorded (other than Unknowns or
those before three weeks) of Progression, provided this occurs within eight

weeks of registration.

NASS Inadequate Assessment, Response Unknown: Progression greater than
eight weeks after registration and either all objective statuses prior to
registration are unknown or the only known objective statuses occurred less
than three weeks after registration.

Baseline and Follow-up Studies

In order to assess the patient’s response to treatment, it is crucial that we get an accurate
depiction of the patient’s disease status at baseline. And since each patient’s disease markers
may display in a different manner in the serum, urine, and bone marrow, all patients must have
all of these sites assessed at baseline. Once on study, however, the follow-up tests required to
assess the patient’s response to treatment may differ from patient to patient, depending on what
their disease status was at baseline.

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The disease marker that is examined in the urine is the urine M protein, which is also
sometimes called Bence-Jones protein. This protein is assessed by using two different tests:
urine electrophoresis (UPEP) and urine immunofixation electrophoresis (UIFE). The UIFE
checks for the presence of the M protein and identifies what type of protein it is, and the UPEP
measures the amount of M protein that is present. For SWOG studies, both of these tests must
be performed on 24 hour urine samples, and the M protein must be quantified (given a
numerical value) on the UPEP. Urine M protein measurements obtained from UPEPs done on
random urine samples, or quantified from urine tests that only measure urine kappa and lambda
lights chain levels, are not considered reliable and the values obtained from these tests will not
be accepted by SWOG. At baseline, these tests must be done within 28 days prior to
registration.

In the serum, the disease marker that is examined is the serum M protein. Like in the urine, this
protein is assessed by two tests: serum protein electrophoresis (SPEP) and serum
immunofixation electrophoresis (SIFE). The SIFE checks for the presence and identity of the
serum M protein, and the SPEP quantifies the amount of serum M protein present. For SWOG
studies, the serum M protein must be quantified on the SPEP. At baseline, these tests must be
done within 28 days prior to registration.

In both the serum and urine, the immunofixation tests (SIFE and UIFE) are more sensitive to the
presence of M protein than the protein electrophoresis tests (SPEP and UPEP). So sometimes
the results from the SPEP or UPEP will indicate that there is no M protein, or that if an M protein
is present it is too little to be quantified, but the SIFE or UIFE done on the same sample will
indicate that an M protein is present. This is why the response criteria above specify that for a
patient to be in a complete response or complete remission, both the protein electrophoresis
and the immunofixation tests must be done on the serum and urine, and all tests must be
negative for the presence of M protein.

Additionally, the response criteria based on the International Uniform Response Criteria for
Multiple Myeloma now allows for patient response to be assessed by following a patient’s serum
free light chain levels. These are measured by a serum free light chain assay, which is also
known as a Freelite™ test. As explained in the criteria above, if at baseline the patient’s serum
M protein is < 1 g/dL and urine M protein is < 200 mg/24 hr, the patient may still be considered
to have “measurable disease” if their involved free light chain level is ≥ 10 mg/dL. The patient
will then be assessed for response based on the results from follow-up serum free light assays.
For these patients, at baseline this test must be done within 28 days prior to registration.
Patients who are considered to have “measurable disease” based on their serum and/or urine M
protein levels will only need to have a free light chain assay performed when it appears that the
patient has entered a stringent complete response.

Bone marrow biopsies are done to assess how much of the bone marrow is comprised of
plasma cells and one must be performed within 28 days prior to registration. Additional follow-
up bone marrow biopsies may be required during the study to confirm a patient’s response.

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Multiple Myeloma Response Exercises

The following are exercises in determining patient response to treatment. Please note that the
first two exercises are based on the response criteria for studies activated since January 1,
2006. The last two exercises are based on the criteria for studies activated prior to January 1,
2006.

These exercises distinguish between ‘objective status’ and ‘best response’. Objective status
refers to the patient’s response at each scheduled assessment. Best response is determined
from a sequence of objective status evaluations and refers to the patient’s most favorable
response over all assessments up to that time point.

In multiple myeloma response assessment you will often have to calculate the percent change
in a value from baseline. To calculate this percent change, please use the following formula:

(current value – baseline value) X 100
baseline value

Exercises for Studies Activated Since January 1, 2006

Exercise 1

Parameter Prestudy Week 6 Week 12 Week 18
Serum M protein 1.2 g/dL 0.5 g/dL 0.1 g/dL 0 g/dL
% change from baseline -58.3% -91.7% -100%
Serum IFE present present present present
Urine M protein 350 mg/24h 190 mg/24h 80 mg/24h 70 mg/24h
% change from baseline -45.7% -77.1% -80%
Urine IFE present present present present
Serum calcium 9.5 mg/dl 9.8 mg/dl 9.9 mg/dl 9.6 mg/dl
BM plasma cell % 20%
Plasmacytomas none PR VGPR VGPR
Objective Status UPR UVGPR VGPR
Best Response at Time Point VGPR
Best Response Overall

Note that at week 6, while the urine M protein had only decreased 45.7% from baseline, the
absolute value of the urine M protein was < 200 mg/24h, and thus the patient still met the
criteria for an objective status of Partial Response (PR).

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Exercise 2

Parameter Prestudy Week 6 Week 12 Week 18
Serum M protein 0.3 g/dL 0.1 g/dL 0 g/dL
Serum IFE present lambda present present
Urine M protein 0 mg/24h 0.15 mg/dL 0 mg/24h
Urine IFE absent 103 mg/dL absent
Serum FLC involved lambda 102.85 lambda
Serum FLC kappa 0.01 mg/dL mg/dL 0.22 mg/dL
Serum FLC lambda 298 mg/dL -65.5% 1.28 mg/dL
Serum FLC (involved – 297.99 10.1 mg/dl 1.06 mg/dL
uninvolved) mg/dL
% change in (involved – PR -99.6%
uninvolved) from baseline 10.4 mg/dl UPR
Serum calcium 35% 9.8 mg/dl
BM plasma cell % 5%
% change in BM plasma cell % none -85.7%
from baseline
Plasmacytomas none
Objective Status VGPR
Best Response at Time Point UVGPR
Best Response Overall UVGPR

At baseline this patient’s serum M protein was < 1 g/dL, and the urine M protein was < 200
mg/24h. However, the serum free light chain assay showed an involved free light chain, in this
case lambda, that was ≥ 10 mg/dL. So this patient is considered to have measurable disease,
and is followed by serum free light chain assay.

Please note that an objective status could not be determined for the week 12 assessment.
Since this patient is being followed by serum free light chain assay, if this test is not done we
cannot determine how the patient is responding to treatment. You should always make sure to
do all tests that section 10 requires for your patient (SPEP and/or UPEP or serum free light
chain assay) at every disease assessment.

The week 18 assessment was very close to qualifying as a Complete Response (CR), but the
serum immunofixation electrophoresis test showed that the serum M protein was still present.
Thus, the objective status for this assessment was a Very Good Partial Response (VGPR).

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Exercises for Studies Activated Prior to January 1, 2006

Exercise 3

Parameter Prestudy Week 6 Week 12 Week 18
Serum M protein 8.2 g/dL 1.2 g/dL 0 g/dL 0 g/dL
% change from baseline -85.4% -100% -100%
Serum IFE present present absent absent
Urine M protein 180 mg/24h 50 mg/24h 0 mg/24h 0 mg/24h
Urine IFE present present absent absent
BM plasma cell % 18% 3%
BM cellularity % 70% yes no 50%
Bone lesions 1 REM CR none
Increasing anemia? yes UREM UCR no
Objective Status CR
Best Response at Time Point CR
Best Response Overall CR

The week 18 assessment confirmed that the patient was experiencing a Complete Remission
(CR). Please note that for the week 18 best response to be categorized as a CR a bone
marrow biopsy and a skeletal survey had to be done in addition to the serum and urine studies.

Exercise 4

Parameter Prestudy Week 6 Week 12 Week 18
Serum M protein 0 g/dL 0 g/dL 0 g/dL 0 g/dL
Serum IFE absent absent present present
Urine M protein 480 mg/24h 216 mg/24h 365 mg/24h 615 mg/24h
% change from baseline -55% -24% +28.1%
Urine IFE present present present present
BM plasma cell % 22%
BM cellularity % 80% PR STA PROG
Bone lesions multiple UPR UPR UPR
Objective Status UPR
Best Response at Time Point
Best Response Overall

At week 18 this patient’s urine M protein level increased by 28.1%, which qualified this patient
for an objective status of progression. Please note that in many protocols the study calendar
may request that other extra tests, like a bone marrow biopsy, be done when the patient has
progressed.

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