MULTIPLE MYELOMA

Regimen/Number

Of Patients

Drug Dose and Route

Leukopenia/

Neutropenia

Toxicity

Anemia

Toxicity

Other

Grade III-IV Toxicities

Emetogenic

Potential

Consequences of

Adverse Event(s)

Melphalan

Stem Cell Support

(Moreau P, et al. Blood.

2002;99:731-35)

N = 298

Melphalan 200 mg/m² IV over 30 minutes

day -2

PBSC infusion day 0

PBSC collection with either

G-CSF 10 mcg/kg/d for 6 days or

cyclophosphamide 4 g/m² IV × 1, followed by

G-CSF or G-CSF + stem cell factor until

2 × 10⁶ CD34 cells/kg collected, followed

by 1 cycle of VAD

GM-CSF administered starting day +7 until

granulocyte recovery

After completion of HDT, interferon-α 3 × 10⁶

units SQ TIW given until granulocytes

1,500/μl and platelets > 100,000/μl;

at least through year 1 of transplant

Duration of  neutropenia―

days (median)

Required

G-GM-CSF 75%

RBC transfusions

―1 (median)

Cardiac 0.7%

Mucositis 30%

Pulmonary 1.4%

Renal 2.1%

Hepatic 0.7%

Level 5

Duration of

G-CSF/GM-CSF―

7 days (median)

Duration of IV

antibiotics―

days (median)

Duration of    thrombocytopenia―

7 days (median)

Platelet transfusions―

1 (median)

5 toxic deaths during VAD

No toxic deaths in

the melphalan

200 mg/m² arm

MP

(Oken MM, et al.

Cancer.

1997;79:1561-67)

N = 230

Melphalan 8 mg/m²/d PO days 1-4

Predinsone 60 mg/m²/d PO days 1-4

Repeat cycle every 28 days

Neutropenia

Grade III 29%

Grade IV 8%

Infections 14%

Nausea/Vomiting* 10%

Peripheral Neuropathy* 2%

Alopecia^† 7%

Thrombocytopenia 23%

*Grade II-IV toxicity

^†Grade I-IV toxicity

Days 1-4

level 1

Grade III-IV toxicity

was experienced by

54% of patients

Thalidomide

(singhal S, et al.

N Engl J Med.

1999;341:1565-71)

N = 84

Thalidomide 200 mg PO daily at bedtime

(dose increase every 2 weeks for 6 weeks

up to a dose of 800 mg/day)

Grade III-IV

3.6%

Thrombocytopenia 3.6%

No patients were

discontinued from

therapy due to toxicity

VAD

(Alexanian R, et al.

AM J Hematol.

1990;33:86-89)

N = 175

Vincristine 0.4 mg/d IV continuous infusion

day 1-4

Doxorubicin 9 mg/m²/d IV continuous

infusion days 1-4

Dexamethasone 40 mg PO

days 1-4, 9-12, 17-20

Repeat cycle every 28-35 days

Neutropenia

Grade III

15.4%

Sepsis 30%

Thrombocytopenia

(≥ Grade II) 11%

Days 1-4―

level 2

Infectious mortality 2%

Required hospitalization

for septic

Complications 30%

Removal of catheter

due to thrombus

or infection 14%

Cushingoid features 26%

Irritability requiring durg

therapy 19%

Aggravation of diabetes

requiring insulin 11%