Know Cancer

forgot password

A Phase 2, Multicenter, Single Arm Study to Evaluate the Effect of PAD Followed by Autologous Stem-cell Transplantation(ASCT) on the Concentrations of Bone Metabolites in Patients With Newly Diagnosed Multiple Myeloma(MM)

Phase 2
18 Years
65 Years
Open (Enrolling)
Multiple Myeloma.

Thank you

Trial Information

A Phase 2, Multicenter, Single Arm Study to Evaluate the Effect of PAD Followed by Autologous Stem-cell Transplantation(ASCT) on the Concentrations of Bone Metabolites in Patients With Newly Diagnosed Multiple Myeloma(MM)

After providing written informed consent, subjects will be evaluated for eligibility during
a 14-day screening period. Eligible subjects will receive 4 cycles PAD treatment prior to
ASCT. Bisphosphonate therapy can be administered as medically indicated and according to
local practice.

After the end of the treatment phase, there will be 18 months follow-up period for every
patient with visits at 4, 6, 12 and 18 months after the end of the treatment phase. In case
the disease progresses before completing the 18 months of follow-up and once the subject
started alternative MM treatment, study assessments will stop, except for survival follow-up
which will be collected every 6 months by either a telephone call or a visit to the study
site. The follow-up for survival will continue for all subjects until the last subject has
completed follow-up. One interim analysis of efficacy and safety will be performed when all
subjects have achieved the end of treatment. Safety will be assessed by the monitoring of
adverse events, physical examination, vital signs measurements and clinical laboratory

Inclusion Criteria:

1. Man or woman aged 18 to 65 years old;

2. Subjects are newly diagnosed MM patients which are scheduled by the investigators to
be treated with vincristine, adriamycin and dexamethasone standard therapy. Stage
II/III (according to Durie and Salmon criteria) with skeletal involvement, such as
bone pain, bone lytic lesions, diffuse osteoporosis or pathologic fractures;

3. Life expectancy > 3 months;

4. Patient has measurable disease in which to capture response, defined as one or more
of the following;

- Serum M-protein level >10.0 g/L measured by serum protein electrophoresis or
immunoglobulin electrophoresis; or

- Urinary M-protein excretion > 1 g/24 hours; or

- Bone marrow plasmacytosis of > 30% by bone marrow aspirate and/or biopsy; or

- Serum free light chains (by the Freelite test) > 2 X the upper limit of normal
(ULN), in the absence of renal failure.

5. Performance status (PS) of ECOG ≤2.0, unless PS of 3-4 based solely on bone pain;

6. Patients must have a Platelets count≥50×109 cells /L; Absolute neutrophil count
(ANC)≥0.75×109 cells /L;

7. Patients must have adequate hepatic function defined as Alanine transaminase(ALT) ≤
2.5 × upper limit of normal(ULN); Aspartate transaminase (AST) ≤2.5×ULN; Total
bilirubin ≤2×ULN;

8. Patients must have adequate renal function defined as creatinine clearance >30 ml

9. Subjects (or their legally acceptable representatives) must have signed a informed
consent document indicating that they understand the purpose of and procedures
required for the study and are willing to participate in the study.

Exclusion Criteria:

1. Non-secretory MM, unless the patient has measurable lesions on computed tomography
(CT), magnetic resonance imaging (MRI) and/or positron emission tomography (PET);

2. Peripheral neuropathy or neuropathy pain grade 2 or high as defined by National
Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE) Version 3;

3. Uncontrolled or severe cardiovascular disease, including myocardial infarction (MI )
within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV
heart failure, uncontrolled angina, clinically significant pericardial disease, or
cardiac amyloidosis;

4. History of allergy reaction attributable to compounds containing boron or mannitol;

5. Any serious, active disease or psychiatric illness that could potentially interfere
with the completion of treatment according to this protocol or the investigator's

6. Concurrent treatment with another investigational agent;

7. Female subject who is pregnant or breast-feeding.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Bone markers measurement

Outcome Description:

The following serum biochemical markers of bone remodeling are going to be measured: 1) bone formation marker : PICP, b ALP; 2) bone resorption marker: ICTP; 3) osteoclast stimulators: OPG, sRANKL;4) osteoblast inhibitor: DKK-1. All these markers are going to be measured on serum samples as previously described by ELISA methodology at baseline, on day 28 of cycles 1,4, and after 4, 6, 12 and 18 months of follow-up or until start of alternative MM treatment, if earlier.

Outcome Time Frame:

Up to Cycle 4 with 28 days per cycle

Safety Issue:


Principal Investigator

Jian Hou, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Shanghai Changzheng Hospital


China: Food and Drug Administration

Study ID:




Start Date:

December 2012

Completion Date:

December 2016

Related Keywords:

  • Multiple Myeloma.
  • Multiple myeloma
  • PAD
  • ASCT
  • Bone metabolites
  • Bone marker
  • Multiple Myeloma
  • Neoplasms, Plasma Cell