Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison of Melphalan-Prednisone(MP),MP-THALIDOMIDE,and Autologous Stem Cell Transplantation in the Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma.
Brief Summary: In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been used since the 1960s and is regarded as the standard of care in elderly patients. We assess whether the addition of thalidomide to this combination or adapted high-dose chemotherapy, using a melphalan 100 mg/m2 -based regimen, would improve survival.


Options:
A: Inclusion Criteria:

* Patients with Multiple Myeloma of IgG, IgA, IgD, IgE, IgM lambda or kappa light chain, low secretory or non-secretory disease
* WHO performance status 0,1,2,or 3
* No prior treatment of multiple myeloma
* Clear requirement of treatment (usually Durie/Salmon stage II or III)
* Anticipated life expectancy of at least 3 months
* Adequate organ function
* Minimum recovery period of 2 weeks following any major surgical procedure before entry into this study
* Women, who are sterilized via hysterectomy or bilateral tubal ligation or at least one year post-menopausal
* Age of at least 19 years, there is no upper age limit patients must have been informed and must have signed an informed consent

Exclusion Criteria:

* Extramedullary plasmocytoma or solitary plasmocytoma without evidence of dissemination of disease
* Benign monoclonal gammopathy
* Multiple myeloma of IgM without osteolytic bone lesions
* Smouldering myeloma
* More than 3 irradiation fields
* Irreversible performance status of WHO4
* Prior treatment of myeloma with any of the following: chemotherapeutic or immunomodulatory agents, corticosteroids, antiangiogenic agents or other investigational drugs
* Women of childbearing potential
* Preexisting peripheral polyneuropathy
* Congestive heart failure NYHA III, IV
* Acute infection requiring systemic antibiotics at study entry until resolved
* Any uncontrolled underlying medical condition (eg diabetes, glaucoma)
* Second primary malignancy (with the exception of cervical carcinoma in situ and non-myeloma skin malignancies) unless patient has been disease-free for at least three years
B: Inclusion Criteria:

* Age above 55 years old.
* Diagnosis of MM (Appendix A) and staging (Appendix B), previously untreated.
* Performance status ECOG, 0, 1, or 2 (Appendix C).
* Written informed consent to the study medications and bone marrow biopsy at diagnosis, 12 weeks and 6 months and/or off-study assessment.
* Women who are pregnant or lactating at the time of diagnosis are ineligible. All women of child-bearing potential must have a negative pregnancy test within 24hrs of commencing the thalidomide and must take adequate precautions to prevent pregnancy and should not plan on conceiving children during the treatment program:

  * Adequate precautions are defined as "at least one highly effective method i.e., IUD, hormonal (birth control pills, injections, or implants), tubal ligation, partner's vasectomy AND one additional effective method i.e., latex condom, diaphragm, cervical cap".
  * Women becoming pregnant on protocol will be removed immediately from protocol.
  * Male patients (including patients having had a vasectomy) must use barrier contraception during and for four weeks after completing the thalidomide.
* Patients remain eligible in the presence of abnormal renal function and/or liver function at time of enrollment.
* Absence of severe dementia, able to take medication at home.
* Absence of systemic disorders (gastrointestinal, pulmonary, cardiac and neurological).

Exclusion Criteria:

* Asymptomatic myeloma or solitary plasmacytoma of bone or extramedullary plasmacytoma (without evidence of myeloma).
* Previous or concurrent active malignancies, except surgically removed basal cell carcinoma of the skin or other in situ carcinomas.
* Previous treatment for myeloma, except minimal local radiotherapy to relieve bone pain.
* Other illnesses which would preclude chemotherapy administration or patient compliance.
* Any other serious medical or psychiatric illness which would prevent informed consent.
* Peripheral neuropathy \> NCI criteria grade 2.
* Pregnant or lactating women and patients of childbearing age who refuse to use contraception.
* History of hypersensitivity to thalidomide or any component of the medications.
C: Inclusion Criteria:

* Confirmed diagnosis of previously untreated multiple myeloma and not a candidate for high dose chemotherapy with stem cell transplantation
* Eastern cooperative oncology group performance status score of less than or equal to 2
* Measurable secretory disease, defined as either serum monoclonal paraprotein greater than or equal to 1 g/dL or urine monoclonal protein greater than 200 mg/24 hours
* Adequate laboratory results that will be confirmed by a study physician
* Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

* Diagnosed with primary amyloidosis, asymptomatic or smoldering multiple myeloma or monoclonal gammopathy of undetermined significance
* Diagnosed with Waldenstrom's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
* Received prior or current systemic therapy or stem cell transplantation for multiple myeloma
* Peripheral neuropathy or neuropathic pain (Grade 2 or higher)
* Received radiation therapy, plasmapheresis or surgery within 14 days
* Transplanted solid organ, with the exception of a corneal transplant
* Serious concurrent illness or history of uncontrolled heart disease
D: Inclusion Criteria:

* Stage II or III multiple myeloma according to Durie and Salmon criteria.
* Patients between 65 and 75 years of age
* Previously untreated patients

Exclusion Criteria:

* Prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma)
* Primary or associated amyloidosis
* World Health organisation performance index of at least 3
* Significant renal insufficiency with creatinine serum levels of 5.0 mg per deciliter or more
* Cardiac or hepatic dysfunction
* Cerebral circulatory insufficiency
* Absolute contraindication to corticosteroids
* Peripheral neuropathy
* HIV or hepatitis B or C positivity
* Patients who had geographic, social or psychological conditions which might prevent adequate follow-up

Answer: D