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NCT01690143 · ClinicalTrials.gov registry record · Phase 1

Carfilzomib + High Dose Melphalan as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation

A Phase 1 study of Multiple Myeloma, sponsored by University of Alabama at Birmingham.

Completed
Registry status
Phase 1
Development phase
45
Enrollment target
4
Study locations

NCT01690143: Completed Phase 1 study of Multiple Myeloma, sponsored by University of Alabama at Birmingham.

NCT01690143 is a Phase 1 study of Multiple Myeloma that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 45 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (92% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01690143, a Phase 1 study of Multiple Myeloma, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
Phase 1
Development phase
45 participants
Enrollment target
4
Study locations

Study Summary

This study is for patients that have multiple myeloma that has come back or relapsed and their condition indicates a procedure called an Autologous Hematopoietic Stem Cell Transplantation (AHSCT). AHSCT is a procedure when stem cells from bone marrow or blood are removed before high-dose chemotherapy. Afterwards, the removed stem cells are put back into the patient's body to form a new population of blood cells. The high-dose chemotherapy administered before the AHSCT is called "Conditioning Therapy." The FDA has approved the use of the drug melphalan as a conditioning therapy. This research study will look at whether adding the study drug called carfilzomib will improve participant outcomes. Carfilzomib is considered investigational and is not approved by the FDA for the treatment of relapsed multiple myeloma. This study is divided into two phases. Phase I: Dose Escalation Phase: The main purpose of Part I of this study is to examine the safety of the study drug, carfilzomib, and determine the safest amount of the study drug that can be given to subjects who have multiple myeloma. Subjects on this study will receive different dose levels of the study drug. If you are one of the first three subjects to receive the study drug, it will be at what is called the 'starting dose' for the study which is the lowest dose that is expected to be tolerated based on prior research. After the first set of participants receive the study drug, the study doctor will review their health to see how they are tolerating the treatment. This will decide if the study drug dosage will be increased or decreased for the next set of subjects who join the study. It is anticipated that 12- 18 participants will enroll in the Phase I portion of this study. Phase II: Safety Confirmation Phase: Once the study doctor has discovered the highest possible dose of study drug that subjects can tolerate, up to 28 more subjects may be enrolled at that dose level. The main purpose of the Phase II porti

Primary Outcome

The maximum tolerated dose of carfilzomib that can be safely combined with high dose melphalan as conditioning regimen prior to autologous hematopoietic cell transplantation in patients with relapsed multiple myeloma meeting eligibility criteria.

Conditions Studied

Multiple Myeloma

Interventions

  • DRUG Melphalan
  • DRUG Carfilzomib

Study Locations (4)

Alabama

  • UAB - Birmingham

New York

  • Memorial Sloan Kettering Cancer Center - New York

South Carolina

  • Medical University of South Carolina Hollings Cancer Center - Charleston

Wisconsin

  • Medical College of Wisconsin - Milwaukee

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2012-05
Est. Completion 2017-11-01
Phase Phase 1
University of Alabama at Birmingham

1,160 total trials

What the finished NCT01690143 record still lists

NCT01690143 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (92% lower).

The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which Melphalan is the first listed.

NCT01690143 reports a single indexed study location in Alabama, New York, South Carolina.

Frequently Asked Questions

What is clinical trial NCT01690143 about?

NCT01690143 is a clinical study titled "Carfilzomib + High Dose Melphalan as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation". This study is for patients that have multiple myeloma that has come back or relapsed and their condition indicates a procedure called an Autologous Hematopoietic Stem Cell Transplantation (AHSCT). AHSCT is a procedure when stem cells from bone marrow or blood are removed before high-dose chemotherap...

What is the current status of trial NCT01690143?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2012-05. Estimated completion is 2017-11-01.

What conditions does trial NCT01690143 study?

This clinical trial studies the following conditions: Multiple Myeloma.

What interventions are being tested in trial NCT01690143?

The interventions under investigation include: Melphalan (DRUG), Carfilzomib (DRUG).

Who is sponsoring clinical trial NCT01690143?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01690143 being conducted?

This trial has 4 study locations across Alabama, New York, South Carolina, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Multiple Myeloma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01690143's enrollment target sits among peer trials

45 273rd of 438 higher than 163 of 438 other Multiple Myeloma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01690143, the US trial registry maintained by the National Library of Medicine. NCT01690143 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.