Test Dose CE Melphalan 10mg/m2 with PK studies Day -12 to Day-3, CE Melphalan Dose of Target AUC 13 mg/L/h infused with PK studies Day -2, 3-10 x 10^6 CD 34+ cells/kg reinfused Day 0, Pegfilgrastim 6mg injection Day +1

Multiple Myeloma

Amyloidosis

Melphalan

Pegfilgrastim

Autologous Hematopoietic Progenitor Cell Transplant

Memorial Sloan Kettering Cancer Center

Study of Captisol Enabled Melphalan and Pharmacokinetics for Patients With Multiple Myeloma or Light Chain Amyloidosis That Are Receiving an Autologous Transplant.

Pharmacokinetic (PK)-Directed Dosing of Captisol Enabled Melphalan for Patients With Multiple Myeloma or Light Chain (AL) Amyloidosis Undergoing High Dose Therapy and Autologous Hematopoietic Progenitor Cell Transplant

defined as stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) to high-dose CE melphalan in patients enrolled in the study between days 90-100 post-AHCT. Responses will be evaluated by the IMWG Response Criteria and Minor Response (MR) criteria. Responses will be evaluated by the standard AL Amyloid Organ Response Criteria.

Spectrum Pharmaceuticals, Inc

The patients receive armodafinil for all 56 days of the study.

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).

The patients receive armodafinil for all 56 days of the study.
armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.

Armodafinil

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.
Placebo: Placebo taken at 150 mg daily. Taken orally as three 50 mg tablets.

Placebo-First

Total

Sex: Female, Male

Race (NIH/OMB)

Grade ECOG Performance status
0 Fully active, performance without restriction
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
Dead

ECOG (Eastern Cooperative Oncology Group)

BFI scale: 9 items; range=0-90 (0-10 per item) Mild = 1-3 Moderate = 4-7 Severe = 8-10

Fatigue (baseline)-Brief Fatigue Inventory (BFI)

ICD-10 Criteria (Range: 0-14) A1-A11 Fatigue Criteria B. Clinically significant distress or impaired functioning C. Symptoms are a consequence of cancer or cancer therapy D. Symptoms are a consequence of comorbid psychiatric disorders

Fatigue (baseline)-International Classification of Diseases version 10 (ICD-10)

Survey measuring fatigue. The scale contains 9 items; range=0-90 (0-10 per item). Mild = 1-3 Moderate = 4-7 Severe = 8-10

The patients receive armodafinil for all 56 days of the study.
Armodafinil taken orally at 150 mg daily.

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.

BFI Score

Cognitive test that gives a measure of various aspects of cognitive performance. Used to measure cognitive fatigue. The test consists of 25 circles containing 13 sequential numbers (1-13) and 12 sequential letters (A-L) positioned.
The test evaluates the time to correctly order letters and numbers; low times = better performance.

Trail Making Test B Score (TMT-B)

Test to evaluate neurocognitive functions (attention, visual scanning and motor speed). The test consists of a key =9 graphic symbols numbered 1 to 9 and the test =120 graphic symbols to be matched with its number. The test evaluates the number of correct matches within 90 seconds. Higher scores= better performance

Symbol Digit Modalities Test Score (SDMT)

Test evaluates working memory and attention. The test consists of repeat numeric sequences of 2 to 9 numbers forward or backwards and evaluates the number of items from a sequence correctly named. Higher scores = better performance.

Digit Span Test Score

Survey addressing fatigue and patient happiness, coping, etc. Used to assess quality of life. The test consists of 40 items, each item with a response scale of 0-4. Higher scores denote better status Items are added to provide the total score (range 0-160).

Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score

Survey used to assess depression and anxiety. The test consists of 14 items (7 for anxiety and 7 for depression); there are 4 possible answers for each statement. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores= more anxiety or depression.

Hospital Anxiety and Depression Scale (HADS) Score

Survey assessing sleep patterns. The test consists of 8 items. The response scale range is 0-24 (range 0-3 per item: 0-No chance to falling asleep; 3-high chance of falling asleep). Interpretation: 0-No chance to falling asleep; 10+ above average chance daytime sleepiness

Epworth Sleepiness Scale (ESS) Score

Overall Study

Director of Clinical Operations

The patients receive armodafinil for all 56 days of the study.
Armodafinil taken orally at 150 mg daily. All patients receiving armodafinil, including patients that crossover, were evaluated for adverse events (AEs) and serious adverse events (SAEs).

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).
Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.
AEs presented were those occurring during from Day 1 to Day 28 only

Fatigue

Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.

armodafinil

Placebo taken at 150 mg daily. Taken orally as three 50 mg tablets.

multiple myeloma/κάλιο

Study of Captisol Enabled Melphalan and Pharmacokinetics for Patients With Multiple Myeloma or Light Chain Amyloidosis That Are Receiving an Autologous Transplant.

A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma

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