Phase 2
Completed N=104
Velcade Consolidation Bone Study
Source: ClinicalTrials.gov NCT01286077 ↗Enrolled (actual)
104
Serious AEs
8.6%
Results posted
Dec 2013
Primary outcomePrimary: Change From Baseline in Bone Mineral Density (BMD) in the Spine at End of Treatment (EOT) — 0.0214; 0.0167 g/mm2
Summary
The purpose of this study is to assess the effect of bortezomib on myeloma-related bone disease, analyzing bone mineral density (BMD) in patients with Multiple Myeloma (MMY) who have received high dose chemotherapy and autologous stem cell transplantation for primary treatment of MMY (single- or double-transplant). Eligible patients will be randomized (study treatment assigned by chance like flipping a coin) to either bortezomib or observation alone. Patients in the bortezomib arm will receive treatment of bortezomib for a total of 4 cycles. All subjects will be followed for a total of 24 months after randomization.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Bone Mineral Density (BMD) in the Spine at End of Treatment (EOT) |
0.0214; 0.0167 | — |
| PRIMARY Change From Baseline in Bone Mineral Density (BMD) in the Femur at End of Treatment |
0.0053; 0.0044; 0.0071; 0.0138 | — |
| SECONDARY Progression Free Survival |
39.56; 31.66 | — |
| SECONDARY Change From Baseline in Biochemical Bone Markers:Carboxyterminal Telopeptide of Type I Collagen (ICTP), Osteocalcin, Bone-specific Alkaline Phosphatase (BAP) |
-4.11; -3.51; 20.15; 14.59; -0.48; -2.11 | — |
| SECONDARY Change From Baseline in Biochemical Bone Markers: Carboxyterminal Collagen Crosslinks (CTX-I) |
-66.50; -77.68 | — |
| SECONDARY Change From Baseline in Biochemical Bone Markers: Dickkopf Homolog 1 (DKK-1) |
-39.31; -25.15 | — |
| SECONDARY Number of Patients With Skeletal Events |
0; 0 | — |
| SECONDARY Appearance of New Bone Lesions Compared to Baseline |
0; 0 | — |
| SECONDARY Change From Baseline in Spine T-score |
1.2028; 1.1811 | — |
| SECONDARY Karnofsky Performance Status |
92.4; 91.7; 0.0; 0.4 | — |
| SECONDARY Overall Survival |
49.90; 47.26 | — |
| SECONDARY Change From Baseline in Quality of Life Assessed by Euro Quality of Life (EQ-5D) |
-0.3; 2.9 | — |
| SECONDARY Tumor Response: Percentage of Participants With Very Good Partial Response (VGPR) or Stringent Complete Response (sCR) or Complete Response (CR) Based on International Myeloma Working Group (IMWG) Response Criteria |
82.6; 72.3 | — |
| SECONDARY Tumor Response: Percentage of Participants With Stable Disease (SD) or Progressive Disease (PD) Based on International Myeloma Working Group (IMWG) Response Criteria |
6.5; 19.1 | — |
| SECONDARY Tumor Response: Percentage of Participants With Partial Response (PR) Based on International Myeloma Working Group (IMWG) Response Criteria |
8.7; 8.5 | — |
Eligibility Criteria
Inclusion Criteria
- Adult Multiple Myeloma patients in partial response or better after high dose chemotherapy and autologous stem cell transplantation
- Patient fulfills defined laboratory requirements within 14 days before enrolment
- If female, is either postmenopausal for more than 24 consecutive months or surgically sterilized or willing to use an acceptable method of birth control for defined period
- If male, agree to use an acceptable barrier method of contraception and to not donate sperm up to 3 months following treatment
Exclusion Criteria
- Patient received another antimyeloma or experimental therapy following autologous stem cell transplantation
- Patient has a peripheral neuropathy or neuropathic pain of grade 2 or greater intensity as defined by the NCI common terminology criteria of adverse event (NCI CTCAE) version 3.0
- Patient has an uncontrolled or severe cardiovascular disease within 6 months of enrolment
- Patient has any conditions that would compromise his/her well-being or the completion of the study requirements
Data sourced from ClinicalTrials.gov (NCT01286077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.