Dosage Schedule for Velcade-MP
This chart shows how Velcade might be given in combination with melphalan and prednisone (Velcade-MP).
| Cycles 1 to 4 (twice-weekly Velcade) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week | 1 | 2 | 3 | 4 | 5 | 6 | ||||||
| Velcade | Day 1 | -- | -- | Day 4 | Day 8 | Day 11 | Rest | Day 22 | Day 25 | Day 29 | Day 32 | Rest |
| MP | Day 1 | Day 2 | Day 3 | Day 4 | -- | -- | Rest | -- | -- | -- | -- | Rest | Cycles 5 to 9 (once-weekly Velcade) |
| Week | 1 | 2 | 3 | 4 | 5 | 6 | ||||||
| Velcade | Day 1 | -- | -- | -- | Day 8 | -- | Rest | Day 22 | -- | Day 29 | -- | Rest |
| MP | Day 1 | Day 2 | Day 3 | Day 4 | -- | -- | Rest | -- | -- | -- | -- | Rest |
| VISTA Frontline Trial - Most Common Side Effects (all grades) | ||
|---|---|---|
| Side Effect | Velcade-MP Percentage of patients (N=340) |
MP Percentage of patients (N=337) |
| Thrombocytopenia | 52% | 47% |
| Neutropenia | 49% | 46% |
| Nausea | 48% | 28% |
| Peripheral neuropathy | 47% | 5% |
| Diarrhea | 46% | 17% |
| Anemia | 43% | 55% |
| Constipation | 37% | 16% |
| Neuralgia (nerve pain) | 36% | 1% |
| Low white blood cell count | 33% | 30% |
| Vomiting | 33% | 16% |
| Fever | 29% | 19% |
| Fatigue | 29% | 26% |
| Low lymphocyte count | 24% | 17% |
| Decreased appetite or weight loss | 23% | 10% |
| Weakness, malaise | 21% | 18% |
| Cough | 21% | 13% |
| Difficulty in sleeping | 20% | 13% |
| Swelling in the hands or feet | 20% | 10% |
Dose Modifications To Be Made During Treatment Cycles of Combination Velcade, Melphalan, and Prednisone Therapy
| Toxicity | Dose Modification or Delay |
| If prolonged very serious (Grade 4) neutropenia or thrombocytopenia is experienced during a cycle, or thrombocytopenia with bleeding is observed in the previous cycle | Consider reduction of the melphalan dose by 25% in the next cycle |
| If platelet count is =30 x 109/L or absolute neutrophil count (ANC) is =0.75 x 109/L on a Velcade dosing day (other than day 1) | Velcade dose should be withheld |
| If several Velcade doses in consecutive cycles are withheld due to toxicity | Velcade dose should be reduced by one dose level (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to 0.7 mg/m2) |
| Serious (Grade 3) or higher non-hematological toxicities | Velcade therapy should be withheld until symptoms of the toxicity have resolved to Grade 1 or baseline. Then, Velcade may be restarted with one dose level reduction (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to 0.7 mg/m2). For Velcade-related neuropathic pain and/or peripheral neuropathy, hold or modify Velcade as outlined here. |
Recommended Dose Modifications for Velcade-related Neuropathic Pain and/or Peripheral Sensory or Motor Neuropathy
| Severity of Peripheral Neuropathy Signs and Symptoms | Modification of Dose and Regimen |
| Grade 1* (asymptomatic; loss of deep tendon reflexes or paresthesia [sensations of numbness, tingling, or prickling]) without pain or loss of function | No action |
| Grade 1 with pain or Grade 2 (moderate symptoms; symptoms that limit instrumental activities of daily living [eg, meal preparation, shopping, using the telephone, etc.]) | Reduce Velcade dose to 1.0 mg/m2 |
| Grade 2 with pain or Grade 3 (severe symptoms; symptoms that limit self-care activities of daily living [eg, bathing, dressing, feeding self, toileting, etc.]) | Withhold Velcade therapy until toxicity resolves. When toxicity resolves, reinitiate with a reduced dose of Velcade at 0.7 mg/m2 and change treatment schedule to once per week. |
| Grade 4 (life-threatening consequences; urgent intervention indicated) | Discontinue Velcade |
Recommended Starting Dose Modification for Velcade in Patients with Hepatic Impairment
This chart shows how the starting dose of Velcade should be modified in patients with liver (hepatic) impairment.
| Level of impairment* | Bilirubin level | SGOT (AST) level | Modification of Velcade starting dose |
| Mild | ≤ 1.0 x ULN | > ULN | None Needed |
| > 1.0 x – 1.5 x ULN | Any | None Needed | |
| Moderate | > 1.5 x – 3.0 x ULN | Any | First cycle: Reduce Velcade to 0.7 mg/m2 Subsequent cycles: Consider raising dose to 1.0 mg/m2 if tolerated well, or reducing dose further if necessary |
| Severe | > 3.0 x ULN | Any |
Abbreviations: AST = aspartate aminotransferase; SGOT = serum glutamic oxaloacetic transaminase; ULN = upper limit of the normal range.
*Liver impairment is noted by increased levels of certain substances that can be measured in the blood. These include bilirubin, a breakdown product of red blood cells that is normally removed by the liver, and the liver enzyme SGOT, which is also called AST.
| APEX Trial - Most Common Side Effects (all grades) | ||
|---|---|---|
| Side Effect | Velcade Percentage of Patients (N=331) |
DexamethasonePercentage of Patients (N=332) |
| Asthenic conditions (fatigue, malaise, weakness) | 61% | 45% |
| Diarrhea | 57% | 21% |
| Nausea | 57% | 14% |
| Constipation | 42% | 15% |
| Peripheral neuropathy* | 36% | 9% |
| Vomiting | 35% | 6% |
| Fever | 35% | 16% |
| Thrombocytopenia | 35% | 11% |
| Psychiatric disorders | 35% | 49% |
| Decreased appetite or weight loss | 34% | 9% |
| Tingling sensation and impairment of sensitivity | 27% | 11% |
| Anemia | 26% | 22% |
| Headache | 26% | 13% |
| Cough | 21% | 11% |
*Represents treatment emergent neuropathy
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