Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndrome, Myelodysplastic Syndrome, Secondary Myelodysplastic Syndrome
Conditions
Keywords
myelodysplastic syndrome, chronic myelomonocytic leukemia, bone marrow transplant, hypomethylating agent, induction chemotherapy
Brief summary
This randomized clinical trial studies different chemotherapies in treating patients with myelodysplastic syndrome before donor stem cell transplant. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells, and may prevent the myelodysplastic syndrome from coming back after the transplant. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
Detailed description
OUTLINE: Patients are randomized to 1 of 2 treatment arms. Arm A: Patients receive decitabine or azacitidine intravenously (IV) or subcutaneously (SC) for 7 days. Treatment repeats every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity. Arm B: Patients receive induction-like chemotherapy per standard of care or per experimental protocol. This study does not require a specific chemotherapy regimen for Arm B. After completion of study treatment, patients are followed up for 18 months.
Interventions
Given IV or SC
DRUGDecitabine
Given IV or SC
OTHERQuality-of-Life Assessment
Ancillary studies
Sponsors
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of de novo or secondary myelodysplastic syndrome (MDS), including chronic myelomonocytic leukemia, as defined by the 2008 World Health Organization classification system * Patients must have measurable disease requiring cytoreduction, defined as a bone marrow myeloblast count \>= 5% and \< 20% on morphologic examination or by flow cytometry in cases in which adequate morphologic examination is not possible * Patients must be considered to have an acceptable risk of early mortality with intensive chemotherapy as determined by the attending physician at the time of the initial visit; since the specific therapy within each arm will be determined after randomization, there is no threshold of organ dysfunction or performance status for inclusion * Considered a potential transplant candidate; the attending/treating physician will determine transplant candidacy at the time of consent * Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
Exclusion criteria
* A diagnosis of acute promyelocytic leukemia as defined by the 2008 World Health Organization classification system * Previous treatment for MDS or acute myeloblastic leukemia (AML) with intensive chemotherapy regimen (induction chemotherapy) or hypomethylating agent * Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment * Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) * Females who are pregnant or breastfeeding * Fertile men and women unwilling to use contraceptive techniques during and for 12 months following treatment * Any uncontrolled or significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results * Clinical evidence suggestive of central nervous system (CNS) involvement with MDS unless a lumbar puncture confirms the absence of leukemic blasts in the cerebrospinal fluid (CSF)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure-free Survival (Failure Defined as Death or Relapse) | 18 months | 18-month failure-free survival (failure defined as death or relapse). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTC QLQ-C30 questionnaire will be collected at screening, after completion of therapy (HMA 4-6 month, and up to 6 months for induction-like chemotherapy) just prior to stem cell infusion and 100 (± 14) days after stem cell infusion (HSCT). | The European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) (version 3) is a 30-item cancer-specific questionnaire for measuring the health-related quality of life (QOL) in cancer patients. It includes five functioning scales (physical, PF; role, RF; cognitive, CF; emotional, EF; and social, SF), three symptom scales (fatigue, FA; pain, PA; and nausea and vomiting, NV), a global health status/QOL scale (GL), and six single items (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial impact of the disease and treatment). All items employ a 4-point Likert scale, ranging from 1 (not at all) to 4 (very much) with lower scores representing a better outcome and higher scores a worse outcome; with the exception of two items in the GL scale, which use 7-point scales (1=very poor to 7=excellent) lower scores representing a worse outcome and higher score representing a better outcome. |
| Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | EORTC QLQ-HDC29 questionnaire will be collected after completion of therapy (HMA 4-6 month, and up to 6 months for induction-like chemotherapy) pre stem cell infusion (HSCT), and 100 (± 14) days post stem cell infusion (HSCT). | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire High Dose Chemotherapy (EORTC QLQ-HDC29) is a treatment-specific quality of life questionnaire that addresses treatment specific side effects as well as emotional, social, and family issues for patients treated with high dose regimens and HCT. The QLQ-HDC29 module includes 29 items, consisting of 6 multi-item scales and 8 single-items; all items employ a 4-point Likert scale, ranging from 1 (not at all) to 4 (very much) with lower scores representing a better outcome and higher scores a worse outcome with the exception of question 47 and 52 being the a higher score resulting in a better outcome and lower score a worse outcome. |
| Overall Survival | Up to 18 months | The total length of follow-up will be 18 months from the start of treatment (day 1). Four categories were added for participants alive 18 months from start of treatment (day 1) 1) Participants alive after 18 months from start of treatment who received hematopoietic cell transplantation (HCT); 2) Participants alive after 18months from start of treatment who did not receive HCT.; 3) Participants deceased after 18 months from start of treatment who received HCT; 4) Participants deceased after 18 months from start of treatment who did not receive HCT. |
| Number of Patients Who Relapse Post-transplant | Up to 18 months | To compare which of the two, intensive chemotherapy versus hypomethylating agent-based therapy, have a factor of relapse post hematopoietic cell transplantation (HCT). |
| Number of Participants Who Received a Hematopoietic Cell Transplantation (HCT). | Up to 18 months | Frequency at which the participants received a hematopoietic cell transplantation (HCT) |
Countries
United States
Participant flow
Recruitment details
Participants were recruited based on physician referral at 3 academic medical centers between April 2013 to March 2022. The first participant was enrolled on August 19, 2013 and the last participant was enrolled in September 24, 2021.
Pre-assignment details
This study is a multi-center, open-label randomized study of intensive chemotherapy versus hypomethylating agent-based therapy as the initial pre-transplant cytoreductive therapy in patients with myelodysplastic syndrome. Patients will be randomized to receive treatment with either hypomethylating agent therapy or intensive chemotherapy; they will not receive both.
Participants by arm
| Arm | Count |
|---|---|
| Arm A (Decitabine or Azacitidine) Patients receive decitabine or azacitidine IV or SC per standard of care. Treatment repeats per standard of care, every 28 days for 4 cycles of decitabine or 6 cycles of azacitidine in the absence of disease progression or unacceptable toxicity.
Azacitidine (AZC): Given IV or SC
Decitabine: Given IV or SC
Quality-of-Life Assessment: Ancillary studies | 25 |
| Arm B (Induction-like Chemotherapy Regimen) Patients receive physician choice of standard of care or other experimental protocol using induction-like chemotherapy regimen. No one specific regimen is required. Several regimens are listed in the protocol for example only.
Quality-of-Life Assessment: Ancillary studies | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Not transplanted | 11 | 11 |
| Overall Study | Persistent Disease | 1 | 0 |
| Overall Study | Screen Failure | 1 | 0 |
| Overall Study | Transplanted died prior to 18-months post-transplant follow-up | 5 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Arm A (Decitabine or Azacitidine) | Arm B (Induction-like Chemotherapy Regimen) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 11 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 14 Participants | 27 Participants |
| Age, Continuous | 59.9 years | 60.7 years | 60.3 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 24 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 23 Participants | 21 Participants | 44 Participants |
| Region of Enrollment United States | 25 Participants | 25 Participants | 50 Participants |
| Sex: Female, Male Female | 8 Participants | 10 Participants | 18 Participants |
| Sex: Female, Male Male | 17 Participants | 15 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 16 / 25 | 14 / 25 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Failure-free Survival (Failure Defined as Death or Relapse)
18-month failure-free survival (failure defined as death or relapse).
Time frame: 18 months
Population: Number of subjects enrolled and randomized in each arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A (Decitabine or Azacitidine) | Failure-free Survival (Failure Defined as Death or Relapse) | 6 Participants |
| Arm B (Induction-like Chemotherapy Regimen) | Failure-free Survival (Failure Defined as Death or Relapse) | 10 Participants |
Secondary
Number of Participants Who Received a Hematopoietic Cell Transplantation (HCT).
Frequency at which the participants received a hematopoietic cell transplantation (HCT)
Time frame: Up to 18 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A (Decitabine or Azacitidine) | Number of Participants Who Received a Hematopoietic Cell Transplantation (HCT). | Received hematopoietic cell transplantation | 12 Participants |
| Arm A (Decitabine or Azacitidine) | Number of Participants Who Received a Hematopoietic Cell Transplantation (HCT). | Did not receive hematopoietic cell transplantation | 13 Participants |
| Arm B (Induction-like Chemotherapy Regimen) | Number of Participants Who Received a Hematopoietic Cell Transplantation (HCT). | Received hematopoietic cell transplantation | 13 Participants |
| Arm B (Induction-like Chemotherapy Regimen) | Number of Participants Who Received a Hematopoietic Cell Transplantation (HCT). | Did not receive hematopoietic cell transplantation | 12 Participants |
Secondary
Number of Patients Who Relapse Post-transplant
To compare which of the two, intensive chemotherapy versus hypomethylating agent-based therapy, have a factor of relapse post hematopoietic cell transplantation (HCT).
Time frame: Up to 18 months
Population: Only participants who received a HCT that relapse were assessed for this outcome.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A (Decitabine or Azacitidine) | Number of Patients Who Relapse Post-transplant | Relapse post HCT | 6 Participants |
| Arm A (Decitabine or Azacitidine) | Number of Patients Who Relapse Post-transplant | Did not relapse post HCT | 6 Participants |
| Arm B (Induction-like Chemotherapy Regimen) | Number of Patients Who Relapse Post-transplant | Relapse post HCT | 3 Participants |
| Arm B (Induction-like Chemotherapy Regimen) | Number of Patients Who Relapse Post-transplant | Did not relapse post HCT | 10 Participants |
Secondary
Overall Survival
The total length of follow-up will be 18 months from the start of treatment (day 1). Four categories were added for participants alive 18 months from start of treatment (day 1) 1) Participants alive after 18 months from start of treatment who received hematopoietic cell transplantation (HCT); 2) Participants alive after 18months from start of treatment who did not receive HCT.; 3) Participants deceased after 18 months from start of treatment who received HCT; 4) Participants deceased after 18 months from start of treatment who did not receive HCT.
Time frame: Up to 18 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A (Decitabine or Azacitidine) | Overall Survival | Participants alive after 18 months from start of treatment who received HCT. | 7 Participants |
| Arm A (Decitabine or Azacitidine) | Overall Survival | Participants alive after 18months from start of treatment who did not receive HCT. | 2 Participants |
| Arm A (Decitabine or Azacitidine) | Overall Survival | Participants deceased after 18 months from start of treatment who received HCT. | 5 Participants |
| Arm A (Decitabine or Azacitidine) | Overall Survival | Participants deceased after 18 months from start of treatment who did not receive HCT. | 11 Participants |
| Arm B (Induction-like Chemotherapy Regimen) | Overall Survival | Participants deceased after 18 months from start of treatment who did not receive HCT. | 11 Participants |
| Arm B (Induction-like Chemotherapy Regimen) | Overall Survival | Participants alive after 18 months from start of treatment who received HCT. | 10 Participants |
| Arm B (Induction-like Chemotherapy Regimen) | Overall Survival | Participants deceased after 18 months from start of treatment who received HCT. | 3 Participants |
| Arm B (Induction-like Chemotherapy Regimen) | Overall Survival | Participants alive after 18months from start of treatment who did not receive HCT. | 1 Participants |
Secondary
Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire High Dose Chemotherapy (EORTC QLQ-HDC29) is a treatment-specific quality of life questionnaire that addresses treatment specific side effects as well as emotional, social, and family issues for patients treated with high dose regimens and HCT. The QLQ-HDC29 module includes 29 items, consisting of 6 multi-item scales and 8 single-items; all items employ a 4-point Likert scale, ranging from 1 (not at all) to 4 (very much) with lower scores representing a better outcome and higher scores a worse outcome with the exception of question 47 and 52 being the a higher score resulting in a better outcome and lower score a worse outcome.
Time frame: EORTC QLQ-HDC29 questionnaire will be collected after completion of therapy (HMA 4-6 month, and up to 6 months for induction-like chemotherapy) pre stem cell infusion (HSCT), and 100 (± 14) days post stem cell infusion (HSCT).
Population: The QLQ-HDC29 is a validated and widely used questionnaire to assess QOL in cancer patients. For Arm A (Azacitidine or Decitabine) only 14 subjects submitted EORTC QLQ-HDC29 at pre-HCST and 10 subjects post-HSCT. For Arm B (induction chemo) 13 subjects submitted QLQ-HDC29 at pre-HSCT and 10 subjects post-HSCT. Scores for each question and timepoints were averaged to obtain mean. However, there are some questions were subjects noted N/A and these answered were subtracted from the number analyzed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 38. Have you worried about your weight being too low? | 1.5 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 31. Have you had soreness in your mouth? | 1.2 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 32. Have you had a dry mouth? | 1.36 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 32. Have you had a dry mouth? | 2.0 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 33. Have you had trouble swallowing? | 1.07 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 33. Have you had trouble swallowing? | 1.2 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 34. Did food and drink taste different from usual? | 1.57 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 34. Did food and drink taste different from usual? | 1.9 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 35. Have you had abdominal pains or cramps? | 1.21 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 35. Have you had abdominal pains or cramps? | 1.3 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 36. Have you had skin problems? | 1.71 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 36. Have you had skin problems? | 1.6 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 37. Have you been upset by how the treatment has affected your hair? | 1.43 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 37. Have you been upset by how the treatment has affected your hair? | 2.0 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 31. Have you had soreness in your mouth? | 1.36 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 38. Have you worried about your weight being too low? | 1.6 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 39. Have you had fevers or chills? | 1.43 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 39. Have you had fevers or chills? | 1.3 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 40. Did you urinate frequently? | 2.29 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 40. Did you urinate frequently? | 2.1 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 41. Have you had aches or pains in your bones? | 1.79 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 41. Have you had aches or pains in your bones? | 1.7 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 42. Have you found it difficult to finish things you started? | 1.64 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 42. Have you found it difficult to finish things you started? | 1.6 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 43. Did you worry about the results of examinations and tests? | 1.92 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 43. Did you worry about the results of examinations and tests? | 1.7 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 44. Have you had trouble coping with the hospital stay? | 1.6 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 44. Have you had trouble coping with the hospital stay? | 1.0 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 45. Has the isolation in the hospital troubled you? | 1.66 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 45. Has the isolation in the hospital troubled you? | 1.0 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 46. Have you worried that the blood counts may not recover? | 2.0 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 46. Have you worried that the blood counts may not recover? | 1.5 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 47. How satisfied were you with the preparation for your treatment? | 2.33 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 47. How satisfied were you with the preparation for your treatment? | 2.5 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 48. Have you felt isolated from those close to you (family, friends)? | 1.77 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 48. Have you felt isolated from those close to you (family, friends)? | 1.7 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT49.Have you been concerned about disruption to your family life due to treatment? | 1.92 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29Post HSCT 49.Have you been concerned about disruption to your family life due to treatment? | 1.5 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Pre HSCT 50. How distressing do you think your illness/treatment has been to those close? | 2.62 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Post-HSCT 50. How distressing do you think your illness/treatment has been to those close? | 2.6 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Pre-HSCT 51. Have you felt a need to keep fears/concerns from family or friends? | 1.62 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Post-HSCT 51. Have you felt a need to keep fears/concerns from family or friends? | 1.8 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | Pre-HSCT 52.Has your experience helped u distinguish between important/non-important things in life? | 2.83 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | PostHSCT 52.Has your experience helped u distinguish between important/non-important things in life? | 2.1 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Pre-HSCT 53. Were you worried about your health in the future? | 2.23 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Post-HSCT 53. Were you worried about your health in the future? | 2.5 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Pre-HSCT 54. Have you felt physically less attractive due to illness/treatment? | 2.0 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Post-HSCT 54. Have you felt physically less attractive due to illness/treatment? | 2.4 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Pre-HSCT 55. Have you been concerned about your ability to have children? | 1.75 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Post-HSCT 55. Have you been concerned about your ability to have children? | 1.33 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Pre-HSCT 56. Did having to take your drugs regularly interfere with your daily life? | 1.28 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Post-HSCT 56. Did having to take your drugs regularly interfere with your daily life? | 1.9 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Pre-HSCT 57. Have you been watching yourself closely for any new symptoms? | 2.66 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Post-HSCT 57. Have you been watching yourself closely for any new symptoms? | 3.3 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Pre-HSCT 58. Have you felt less interest in sex? | 2.33 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Post-HSCT 58. Have you felt less interest in sex? | 2.50 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Pre-HSCT 59. Have you felt less sexual enjoyment? | 2.16 units on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Post-HSCT 59. Have you felt less sexual enjoyment? | 2.6 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | PostHSCT 52.Has your experience helped u distinguish between important/non-important things in life? | 3.1 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 31. Have you had soreness in your mouth? | 1.08 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 45. Has the isolation in the hospital troubled you? | 1.0 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 31. Have you had soreness in your mouth? | 1.0 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Pre-HSCT 58. Have you felt less interest in sex? | 2.55 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 32. Have you had a dry mouth? | 1.62 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 46. Have you worried that the blood counts may not recover? | 1.83 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 32. Have you had a dry mouth? | 1.7 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Pre-HSCT 53. Were you worried about your health in the future? | 2.46 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 33. Have you had trouble swallowing? | 1.15 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 46. Have you worried that the blood counts may not recover? | 3.33 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 33. Have you had trouble swallowing? | 1.3 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Post-HSCT 56. Did having to take your drugs regularly interfere with your daily life? | 2.11 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 34. Did food and drink taste different from usual? | 1.92 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 47. How satisfied were you with the preparation for your treatment? | 2.83 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 34. Did food and drink taste different from usual? | 2.2 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Post-HSCT 53. Were you worried about your health in the future? | 2.5 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 35. Have you had abdominal pains or cramps? | 1.38 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 47. How satisfied were you with the preparation for your treatment? | 2.5 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 35. Have you had abdominal pains or cramps? | 1.6 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Pre-HSCT 59. Have you felt less sexual enjoyment? | 2.66 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 36. Have you had skin problems? | 1.38 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 48. Have you felt isolated from those close to you (family, friends)? | 1.77 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 36. Have you had skin problems? | 1.5 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Pre-HSCT 54. Have you felt physically less attractive due to illness/treatment? | 1.92 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 37. Have you been upset by how the treatment has affected your hair? | 1.38 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 48. Have you felt isolated from those close to you (family, friends)? | 1.6 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 37. Have you been upset by how the treatment has affected your hair? | 1.7 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Pre-HSCT 57. Have you been watching yourself closely for any new symptoms? | 2.77 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 38. Have you worried about your weight being too low? | 1.62 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT49.Have you been concerned about disruption to your family life due to treatment? | 2.23 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 38. Have you worried about your weight being too low? | 2.2 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Post-HSCT 54. Have you felt physically less attractive due to illness/treatment? | 2.1 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 39. Have you had fevers or chills? | 1.46 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29Post HSCT 49.Have you been concerned about disruption to your family life due to treatment? | 2.22 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 39. Have you had fevers or chills? | 1 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Post-HSCT 58. Have you felt less interest in sex? | 2.25 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 40. Did you urinate frequently? | 2.0 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Pre HSCT 50. How distressing do you think your illness/treatment has been to those close? | 2.69 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 40. Did you urinate frequently? | 1.4 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Pre-HSCT 55. Have you been concerned about your ability to have children? | 1.25 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 41. Have you had aches or pains in your bones? | 1.46 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Post-HSCT 50. How distressing do you think your illness/treatment has been to those close? | 2.5 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 41. Have you had aches or pains in your bones? | 1.4 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Post-HSCT 57. Have you been watching yourself closely for any new symptoms? | 3.66 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 42. Have you found it difficult to finish things you started? | 1.46 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Pre-HSCT 51. Have you felt a need to keep fears/concerns from family or friends? | 1.84 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 42. Have you found it difficult to finish things you started? | 1.3 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Post-HSCT 55. Have you been concerned about your ability to have children? | 1 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 43. Did you worry about the results of examinations and tests? | 1.66 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Post-HSCT 51. Have you felt a need to keep fears/concerns from family or friends? | 2.2 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 43. Did you worry about the results of examinations and tests? | 1.7 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Post-HSCT 59. Have you felt less sexual enjoyment? | 2.25 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 44. Have you had trouble coping with the hospital stay? | 1.5 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | Pre-HSCT 52.Has your experience helped u distinguish between important/non-important things in life? | 2.54 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Post-HSCT 44. Have you had trouble coping with the hospital stay? | 1.0 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC29 Pre-HSCT 56. Did having to take your drugs regularly interfere with your daily life? | 1.88 units on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. | QLQ-HDC 29 Pre-HSCT 45. Has the isolation in the hospital troubled you? | 1.66 units on a scale |
Secondary
Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire.
The European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) (version 3) is a 30-item cancer-specific questionnaire for measuring the health-related quality of life (QOL) in cancer patients. It includes five functioning scales (physical, PF; role, RF; cognitive, CF; emotional, EF; and social, SF), three symptom scales (fatigue, FA; pain, PA; and nausea and vomiting, NV), a global health status/QOL scale (GL), and six single items (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial impact of the disease and treatment). All items employ a 4-point Likert scale, ranging from 1 (not at all) to 4 (very much) with lower scores representing a better outcome and higher scores a worse outcome; with the exception of two items in the GL scale, which use 7-point scales (1=very poor to 7=excellent) lower scores representing a worse outcome and higher score representing a better outcome.
Time frame: EORTC QLQ-C30 questionnaire will be collected at screening, after completion of therapy (HMA 4-6 month, and up to 6 months for induction-like chemotherapy) just prior to stem cell infusion and 100 (± 14) days after stem cell infusion (HSCT).
Population: The QLQ-C30 is a validated and widely used questionnaire to assess QOL in cancer patients. For Arm A (Azacitidine or Decitabine) only 22 subjects submitted EORTC QLQ-C30 at screening; 14 subjects completed EORTC QLQ-C30 at pre-transplant and 10 subjects post-transplant. For Arm B (induction chemo) 25 subjects submitted EORTC QLQ-C30 at screening; 13 subjects completed QLQ-C30 at pre-transplant and 10 subjects post-transplant. Scores for each question and timepoints were averaged to obtain mean.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 28.Physical condition/medical treatment caused financial difficulties? | 1.71 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 21. Did you feel tense? | 1.72 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 pre-transplant 21. Did you feel tense? | 1.92 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 21. Did you feel tense? | 1.5 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 22. Did you worry? | 2.13 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 22. Did you worry? | 2.0 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 22. Did you worry? | 1.8 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 23. Did you feel irritable? | 1.63 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-Transplant 23. Did you feel irritable? | 1.77 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-Transplant 23. Did you feel irritable? | 1.7 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 24. Did you feel depressed? | 1.68 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-Transplant 24. Did you feel depressed? | 1.41 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-Transplant 24. Did you feel depressed? | 1.5 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 25. Have you had difficulty remembering things? | 1.86 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 25. Have you had difficulty remembering things? | 1.84 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 25. Have you had difficulty remembering things? | 1.9 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 26. Has your physical condition/medical treatment interfere with family? | 1.90 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 26.Has your physical condition/medical treatment interfere w/family? | 2.15 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 26.Has your physical condition/medical treatment interfere w/family? | 1.8 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 27.Has your physical condition/medical treatment interfere w/social life? | 2.09 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30Pre-transplant 27.Has your physical condition/medical treatment interfere w/social life? | 2.5 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-trans 27.Has your physical condition/medical treatment interfere w/social life? | 2.1 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 20. Difficulty concentrating on things like reading a or watching TV? | 1.3 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 28.Physical condition/medical treatment caused financial difficulties? | 2.38 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Posttransplant 28.Physical condition/medical treatment caused financial difficulties? | 2.0 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 29.How would you rate your overall health during the past week? | 4.52 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 29.How would you rate your overall health during the past week? | 4.77 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 29.How would you rate your overall health during the past week? | 5.4 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 30. How would you rate your overall quality of life during the past week? | 4.5 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pretransplant 30.How would you rate your overall quality of life during the past week? | 4.46 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Posttransplant 30.How would you rate your overall QoL during the past week? | 5.1 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Screening 1. Do you have any trouble doing strenuous activities? | 2.27 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Pre-Transplant 1. Do you have any trouble doing strenuous activities? | 2.14 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at post-transplant 1. Do you have any trouble doing strenuous activities? | 2.0 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Screening 2. Do you have any trouble taking a long walk? | 2.40 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Pre-transplant 2. Do you have any trouble taking a long walk? | 1.85 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Post-transplant 2. Do you have any trouble taking a long walk? | 1.9 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Screening 3. Do you have any trouble taking a short walk outside of the house? | 1.5 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Pre-transplant 3. Do you have any trouble taking a short walk outside of the house? | 1.42 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Post-transplant 3.Do you have any trouble taking a short walk outside of the house? | 1.1 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Screening 4. Do you need to stay in bed or a chair during the day? | 1.68 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Pre transplant 4. Do you need to stay in bed or a chair during the day? | 1.42 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Post-transplant 4. Do you need to stay in bed or a chair during the day? | 1.45 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Screening 5. Do you need help with eating, dressing, washing yourself? | 1.04 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Pre-transplant 5. Do you need help with eating, dressing, washing yourself? | 1 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Post-transplant 5. Do you need help with eating, dressing, washing yourself? | 1 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Screening 6. Were you limited in doing either your work or other daily activities? | 2.22 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 6.Were you limited in doing either your work or other daily activities? | 2.07 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-Transplant 6.Were you limited in doing either your work/ other daily activities? | 1.8 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 7.Were you limited in pursing your hobbies or other leisure time activities? | 2.52 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 7.Were you limited in pursing your hobbies/other leisure activities? | 2.07 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 7.Were you limited in pursing your hobbies/other leisure activities? | 1.9 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 8. Were you short of breath? | 2.22 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 8. Were you short of breath? | 1.85 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 8. Were you short of breath? | 1.5 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 9. Have you had pain? | 1.54 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 9. Have you had pain? | 1.78 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 9. Have you had pain? | 1.6 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 10. Did you need to rest? | 2.38 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 10. Did you need to rest? | 2.21 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 10. Did you need to rest? | 1.9 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 11. Have you had trouble sleeping? | 2.0 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 11. Have you had trouble sleeping? | 2.35 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 11. Have you had trouble sleeping? | 2.0 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 12. Have you felt weak? | 2.42 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 12. Have you felt weak? | 1.85 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 12. Have you felt weak? | 2.1 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 13. Have you lacked appetite? | 1.54 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 13. Have you lacked appetite? | 1.71 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 13. Have you lacked appetite? | 1.5 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 14. Have you felt nauseated? | 1.31 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 14. Have you felt nauseated? | 1.07 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 14. Have you felt nauseated? | 1.5 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 15. Have you vomited? | 1.09 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 15. Have you vomited? | 1 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 15. Have you vomited? | 1.1 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 16. Have you been constipated? | 1.31 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 16. Have you been constipated? | 1.21 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 16. Have you been constipated? | 1 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 17. Have you had diarrhea? | 1.45 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 17. Have you had diarrhea? | 1.23 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 17. Have you had diarrhea? | 2.0 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 18. Were you tired? | 2.45 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 18. Were you tired? | 2.23 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 18. Were you tired? | 2.10 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 19. Did pain interfere with your daily activities? | 1.27 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 19. Did pain interfere with your daily activities? | 1.61 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 19. Did pain interfere with your daily activities? | 1.5 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 20. Difficulty concentrating on things like reading a or watching TV? | 1.81 score on a scale |
| Arm A (Decitabine or Azacitidine) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 20. Difficulty concentrating on things like reading a or watching TV? | 1.69 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 13. Have you lacked appetite? | 1.72 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 20. Difficulty concentrating on things like reading a or watching TV? | 1.2 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Post-transplant 5. Do you need help with eating, dressing, washing yourself? | 1 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 21. Did you feel tense? | 1.60 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 18. Were you tired? | 2.20 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 pre-transplant 21. Did you feel tense? | 1.31 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Screening 6. Were you limited in doing either your work or other daily activities? | 1.92 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 21. Did you feel tense? | 1.4 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 13. Have you lacked appetite? | 1.85 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 22. Did you worry? | 1.68 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 6.Were you limited in doing either your work or other daily activities? | 1.61 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 22. Did you worry? | 1.92 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 17. Have you had diarrhea? | 1.20 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 22. Did you worry? | 1.7 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-Transplant 6.Were you limited in doing either your work/ other daily activities? | 1.8 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 23. Did you feel irritable? | 1.41 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 13. Have you lacked appetite? | 1.70 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-Transplant 23. Did you feel irritable? | 1.54 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 7.Were you limited in pursing your hobbies or other leisure time activities? | 1.88 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-Transplant 23. Did you feel irritable? | 1.6 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 19. Did pain interfere with your daily activities? | 1.4 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 24. Did you feel depressed? | 1.48 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 7.Were you limited in pursing your hobbies/other leisure activities? | 1.85 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-Transplant 24. Did you feel depressed? | 1.46 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 14. Have you felt nauseated? | 1.4 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-Transplant 24. Did you feel depressed? | 1.5 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 7.Were you limited in pursing your hobbies/other leisure activities? | 1.8 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 25. Have you had difficulty remembering things? | 1.60 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 17. Have you had diarrhea? | 1.23 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 25. Have you had difficulty remembering things? | 1.54 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 8. Were you short of breath? | 2 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 25. Have you had difficulty remembering things? | 1.6 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 14. Have you felt nauseated? | 1.53 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 26. Has your physical condition/medical treatment interfere with family? | 1.48 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 8. Were you short of breath? | 1.31 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 26.Has your physical condition/medical treatment interfere w/family? | 2.07 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 19. Did pain interfere with your daily activities? | 1.48 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 26.Has your physical condition/medical treatment interfere w/family? | 1.7 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 8. Were you short of breath? | 1.33 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 27.Has your physical condition/medical treatment interfere w/social life? | 1.92 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 14. Have you felt nauseated? | 1.4 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30Pre-transplant 27.Has your physical condition/medical treatment interfere w/social life? | 2.38 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 9. Have you had pain? | 1.48 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-trans 27.Has your physical condition/medical treatment interfere w/social life? | 2.5 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 17. Have you had diarrhea? | 1.5 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 28.Physical condition/medical treatment caused financial difficulties? | 1.56 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 9. Have you had pain? | 1.46 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 28.Physical condition/medical treatment caused financial difficulties? | 1.92 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 15. Have you vomited? | 1.12 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Posttransplant 28.Physical condition/medical treatment caused financial difficulties? | 2.0 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 9. Have you had pain? | 1.4 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 29.How would you rate your overall health during the past week? | 4.86 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 20. Difficulty concentrating on things like reading a or watching TV? | 1.30 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 29.How would you rate your overall health during the past week? | 4.61 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 10. Did you need to rest? | 2.16 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 29.How would you rate your overall health during the past week? | 5.1 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 15. Have you vomited? | 1.08 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 30. How would you rate your overall quality of life during the past week? | 5.12 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 10. Did you need to rest? | 2.15 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pretransplant 30.How would you rate your overall quality of life during the past week? | 4.69 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 18. Were you tired? | 2.4 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Posttransplant 30.How would you rate your overall QoL during the past week? | 5.1 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 10. Did you need to rest? | 2.0 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Screening 1. Do you have any trouble doing strenuous activities? | 1.72 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 15. Have you vomited? | 1.1 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Pre-Transplant 1. Do you have any trouble doing strenuous activities? | 2.0 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 11. Have you had trouble sleeping? | 1.8 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at post-transplant 1. Do you have any trouble doing strenuous activities? | 1.81 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 19. Did pain interfere with your daily activities? | 1.38 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Screening 2. Do you have any trouble taking a long walk? | 1.96 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 11. Have you had trouble sleeping? | 1.69 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Pre-transplant 2. Do you have any trouble taking a long walk? | 1.83 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 16. Have you been constipated? | 1.52 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Post-transplant 2. Do you have any trouble taking a long walk? | 1.63 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 11. Have you had trouble sleeping? | 1.6 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Screening 3. Do you have any trouble taking a short walk outside of the house? | 1.24 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 18. Were you tired? | 2.31 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Pre-transplant 3. Do you have any trouble taking a short walk outside of the house? | 1.30 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 12. Have you felt weak? | 2.04 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Post-transplant 3.Do you have any trouble taking a short walk outside of the house? | 1.4 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 16. Have you been constipated? | 1.38 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Screening 4. Do you need to stay in bed or a chair during the day? | 1.66 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Pre-transplant 12. Have you felt weak? | 1.77 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Pre transplant 4. Do you need to stay in bed or a chair during the day? | 1.30 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Screening 20. Difficulty concentrating on things like reading a or watching TV? | 1.32 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Post-transplant 4. Do you need to stay in bed or a chair during the day? | 1.5 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 12. Have you felt weak? | 1.7 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Screening 5. Do you need help with eating, dressing, washing yourself? | 1.08 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 Post-transplant 16. Have you been constipated? | 1 score on a scale |
| Arm B (Induction-like Chemotherapy Regimen) | Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. | EORTCQLQ-C30 at Pre-transplant 5. Do you need help with eating, dressing, washing yourself? | 1 score on a scale |