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Neoplasms, Plasma Cell clinical trials

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NCT ID: NCT01852799 Completed - Multiple Myeloma Clinical Trials

A Study of PAD Followed by Autologous Stem Cell Transplantation (ASCT) to Treat Newly Diagnosed Multiple Myeloma

Start date: December 2012
Phase: Phase 2
Study type: Interventional

This is a multicentre; single arm study in subjects with newly diagnosed multiple myeloma. The primary objectives of this study is to assess the effect of bortezomib combination therapy (PAD regimen) followed by ASCT on bone metabolites in patients with newly diagnosed multiple myeloma, as measured by ELISA methodology as previously described analyzing the change in biochemical bone marker compared with the baseline value: bone formation marker- bone alkaline phosphatase(bALP) and osteoblast inhibitor- Dickkopf-1(DKK-1). The secondary objectives of this study are: 1. Subgroup analysis for the change from baseline in biochemical bone marker based on whether or not Bisphosphonate was used. 2. Assessment of other bone markers parameters: bone formation marker -carboxy terminal propeptide of type I procollagen (PICP); bone resorption markers -carboxy terminal telopeptide region of type I collagen ( ICTP); osteoclast stimulators -osteoprotegerin(OPG), soluble receptor activator of nuclear factor kappaB ligand(sRANKL); 3. To observe the effect of bortezomib on bone mineral density (BMD) as measured by repeated quantitative CT-scan; 4. The evaluation of Skeletal related events (SRE) and appearance of new bone lesions; 5. To determine progression free survival (PFS), 1 year survival, overall survival and safety profile following treatment with PAD and ASCT as first-line therapy.

NCT ID: NCT01852591 Active, not recruiting - Multiple Myeloma Clinical Trials

Exploration of Immune Response to Early PCV13 Vaccination in Conjunction With Autologous Transplant

PCV13
Start date: February 2013
Phase: N/A
Study type: Interventional

There is no study hypothesis. The purpose of this study is to see if the Pneumococcal conjugate vaccine (PCV13), when administered before and early after an autologous peripheral stem cell transplant will induce an immune response.

NCT ID: NCT01850524 Completed - Multiple Myeloma Clinical Trials

IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma

Start date: April 29, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide continued access to ixazomib and/or lenalidomide to participants who are continuing to have clinical benefit and to continue collecting relevant safety data to monitor safety in participants with Newly Diagnosed Multiple Myeloma (NDMM) who are not eligible for stem cell transplant.

NCT ID: NCT01849848 Completed - Clinical trials for Relapsed/Refractory Multiple Myeloma

Study of SyB L-0501 to Treat Relapsed/Refractory Multiple Myeloma

Start date: November 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the antitumor efficacy and safety of bendamustine (SyB L-0501: 90 mg/m^2/day) for a maximum of 6 cycles (1 cycle: intravenous administration for 2 consecutive days and 26-day observation period) in patients with relapsed/refractory multiple myeloma.

NCT ID: NCT01849783 Completed - Clinical trials for Stage III Multiple Myeloma

Autologous Stem Cell Transplant Followed By Maintenance Therapy in Treating Elderly Patients With Multiple Myeloma

Start date: April 4, 2013
Phase: Phase 2
Study type: Interventional

This phase II trial investigates whether patients greater than or equal to 65 years of age diagnosed with myeloma or another plasma cell malignancy will have better outcomes with transplant followed by maintenance therapy, as primarily measured by progression-free survival, versus non-transplant approaches.

NCT ID: NCT01846429 Terminated - Pain Clinical Trials

Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain

Start date: September 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to: - Determine how well people tolerate sodium bicarbonate taken by mouth in higher doses than those usually given for heartburn. - Determine if sodium bicarbonate can reduce cancer-related pain.

NCT ID: NCT01842308 Completed - Clinical trials for Refractory Plasma Cell Myeloma

Carfilzomib and Melphalan Before Stem Cell Transplant in Treating Patients With Multiple Myeloma

Start date: June 4, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the side effects and best dose of carfilzomib when given together with melphalan and to see how well they work in treating patients with multiple myeloma before stem cell transplant. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving carfilzomib together with melphalan may kill more cancer cells.

NCT ID: NCT01838512 Recruiting - Multiple Myeloma Clinical Trials

Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)

Start date: June 13, 2012
Phase:
Study type: Observational

The purpose of this study is to assess the clinical effectiveness of all approved multiple myeloma (MM) therapies in the newly-diagnosed (NDMM) and the relapsed/refractory MM (RRMM) settings in real-world clinical practice.

NCT ID: NCT01838369 Terminated - Clinical trials for Smoldering Multiple Myeloma

A Phase II Study of BI-505 in Smoldering Multiple Myeloma

Start date: March 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the effect of BI-505 on tumor burden in patients diagnosed with smoldering multiple myeloma.

NCT ID: NCT01832727 Terminated - Multiple Myeloma Clinical Trials

Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma

Start date: July 2, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objectives are: Phase 1b: - To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of oprozomib given orally, once daily, on 2 different schedules. - To evaluate safety and tolerability Phase 2: - To estimate the overall response rate (ORR). - To evaluate safety and tolerability